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NL-Draft proposal (15-11-2006) Generic list health claims: criteria This document is based on a the explanatory notes made by …??. It has been developed to assist companies and other interested parties to compile a list of health claims, based on generally accepted scientific data/knowledge, well understood by the average consumer, describing or referring to (a) The role of a nutrient or other substance in growth, development and the functions of the body, or (b) Psychological and behavioural functions, or (c) Without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet, and the necessary conditions applying to them, as laid down in Article 13 of the proposed Nutrition and Health Claims Regulation. This document describes the template to be used when submitting claims and it includes further details about which claims are within the scope of this list and therefore eligible and guidance on scientific evidence. 1. Format of the list (Art. 13) The nutrition and health claims regulation does not provide for a format of the list under Article 13. It only specifies that the list should contain the claims, the conditions applying to them and the references to the relevant scientific justification. Based on this and in order to be able to collate the scientific information relating to the claims, the following format is proposed by the CIAA: Food Category, Food or Health Conditions of Nature of Food Relationship use (if any) evidence Component References Example of wording Entry 1: Food Category, Food or Food Component Background Article 2.5 defines a health claim as “any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health”. Article 13 refers to ‘the role of nutrients’ and ‘other substances’ in growth, development and the functions of the body. However, health claims are often linked to more complex entities, e.g. a combination of nutrients or substances, a food as a whole or even a combination of foods in a specific diet. In all cases, the effect will be linked to the nutrients or other substances contained in such entities. Therefore, for the purposes of assembling the list of claims, the broadest interpretation of food category, food or food component will be used. 769857186 1 van 10 The diet, food category, food, nutrient, food component, botanical, other substance that is the subject of the health relationship mentioned in the claim should be sufficiently characterised and described (see Table 1). Filling in instructions Table 1: Entry 1 Requirements regarding the provided data A diet A food category A food(product) A constituent: Nutrient A component / a substance A botanical 769857186 the Latin (botanical) and English name, the origin, the plant part used, characteristics of the isolate or extract, including where relevant minimal or maximal limits of active components and specifications on the amount to be used in relation to the relationship and claims listed, etc. Example a diet low in saturated fat or high in fruit and vegetables, high in fibre, low in salt etc fruit and vegetables, whole grain cereals, nuts, oily fish whole oats, salmon, almonds, cranberry juice, tomatoes, fermented dairy products macronutrient such as a protein sources, a carbohydrate source; micronutrients such as a vitamin or mineral whey protein, soy protein, inulin, other fibre materials like oat bran, beta-glucan soluble fibre, omega-3 fatty acid, L-lysine, sterols and stanols, lycopene, lutein, glucosamine, probiotics, prebiotics like fructooligosaccharide (FOS), conjugated linoleic acid (CLA) etc garlic, ginseng, bilberry, ginger, etc 2 van 10 Entry 2: Health Relationship Background Article 13 refers to: The role of a nutrient or other substance in growth, development and the functions of the body, or Psychological and behavioural functions, or Without prejudice to Directive 96/8/EC, slimming or weight control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet. For example, nutrients and other substances can be necessary for and/or contribute to the structure and functions of particular organs and several physiological states, e.g. reproduction, conception, growth and development, body maintenance. The well-established functions of nutrients and other substances are documented extensively in the scientific literature. Article 13 list includes: Specific diets. These may also have specific effects on health in general. These may be listed in so far as the effect of such diets can be attributed to the foods, food components, nutrients or other substances that characterise the specific diet (e.g. high in fibre, low in fat, etc) relate to the maintenance of healthy body functions, organs of the body or health in general, and refer only to maintenance of the healthy state of those body functions or processes (body metabolism, cholesterol, metabolism, digestion etc). Article 13 list excludes: Refer to any food category, food or food component (including a nutrient) that has the property of treating, preventing or curing human disease or make any reference to such a property, i.e. medicinal claims. Nor must a reduction of a disease risk relationship or claim be listed Diets, food categories, foods, nutrients, other substances and botanicals can have specific beneficial effects on physiological, psychological, cognitive functions or biological activities. Ingredients and a whole range of substances can be included as long as they have wellestablished physiological or biological functions in the body. For example, a function of a food category, food or food component can apply to constituents that have cholesterollowering effects, calcium-absorption effects, prebiotic or probiotic effects. Specific physical or chemical properties of a food category, food or food component may influence a particular function, e.g. a low glycaemic index due to specific structural or starch properties. Filling in instructions Table 2: Entry 2 Requirements regarding the provided data listed as precisely as possible, in line with the scientific supportive evidence. In case the benefit is meant for a specific group, this should be mentioned. 769857186 Example 3 van 10 Entry 3: Conditions for the Claim to be Valid Background The general ‘principles’, ‘conditions’ and ‘specific conditions’ of the Regulation on nutrition and health claims, which apply to all health claims, are laid down in Articles 3, 5 and 10, respectively. Article 13 states that claims should be accompanied by the conditions applying to them and by references to the relevant scientific justification, wherever appropriate. Filling in instructions Table 3: Entry 3 Requirements regarding the provided data The quantity of the food category, food or food component that will produce the nutritional or physiological effect claimed. Where relevant, an indication should be given on the specificity of the substance (origin, form etc) and the validity of the claim for a specific food or substance, e.g. by indication of specific analytical methods Where relevant, an indication should be given on the influence of other foods on the availability of the substance/nutrient for use. Example the conditions could relate to an indication of the amount of a food category, food or food component that should be consumed per quantified serving or per day, and whether the health relationship applies only to certain groups of the population. Such as: Soy protein 25g/day Oat beta-glucan 3 g/day Fish oil fatty acids 2 portions/week Fruits and vegetables At least 5 servings/day Vitamins/minerals At least 5 servings/day Botanicals Indication of the amount of the botanical and/or active components in the case of botanicals Example: the effect of fytosterol in fatty foods is higher compare with less fatty/light foods Entry 4: Nature of Evidence Background It is clear from all the existing international laws, codes of practice and guidelines that the claimed effect must be supported by scientifically valid evidence that demonstrates the effect of the nutrient, other substances, food category, food or food component in humans and under conditions that reflect the actual conditions of use and exposure. The relationship between a nutrient, other substances, food category, food or food component and health can be demonstrated by a number of different types of studies and designs. Methodological soundness is critical, given that the validity of the study type depends on the quality of design, execution and analysis. In brief, studies on humans are accorded greater weight than animal and in vitro studies, and human intervention studies have greater weight than observational or epidemiological studies. 769857186 4 van 10 Article 13 claims must be based on generally accepted scientific data/knowledge. Hence, it is necessary to evaluate the totality of the available evidence and weigh up the evidence on a case-by-case basis. In many cases this process of evaluation has already been carried out by expert panels and organisations. This is e.g. the case with the knowledge usually found in recognised textbooks, monographs, scientific opinions by officials scientific bodies (e.g. SCF, EFSA, NAS, etc) and claims already approved by national authorities (e.g. USA FDA, etc). The terminology to be used in completing the template is: Authoritative body Textbook Monographs Critical Reviews Meta-analysis Single Large Human studies Multiple Small Studies The scientific data and knowledge to justify the health claims may come from one or more of these sources. It is only when the food category, food or food component is supported by lower grades of evidence that the individual papers will need to be scrutinised (see table 5, 5c and see H2 Classification of scientific data). Filling in instructions Table 4: Entry 4 Requirements regarding the provided data Example Define whether the evidence is a Authoritative body Textbook Monographs Critical Reviews Meta-analysis Single Large Human studies Multiple Small Studies Entry 5: References Background The references should be complete and allow an expert committee to find the information quickly and efficiently. It is recommended that, for claims that are not underwritten by recognised text books and monographs or groups of independent experts, the key hard copy or electronic version of the individual scientific paper(s) is identified and assessed as set out below. This is essential to enable companies and other interested parties to grade the evidence. It also indicates that the company or other interested party is ready to provide the supporting data if required by the European Commission, the Member States or EFSA. 769857186 5 van 10 Handbook of Nutrition and Food. Edited by Carolyn D Berdanier...[et al.]. Boca Raton, Fla.: CRC Press, 2002. Requirements regarding the provided data a. Evidence accepted by independent expert bodies and national and international committees can include the following sources (nonexhaustive list) b. Evidence from recognised text books and monographs c. Evidence from individual references The relevant data should be extracted objectively from peer-reviewed publications in the scientific literature and presented in a clear, concise manner. [? which data is obligatory, which additional?] 769857186 Example ANZFA: Permitted health claims by Food Standards Australia and New Zealand CEDAP: Commission d’étude des denrées alimentaires destinées à une alimentation particulière (Fr). FDA: Food and Drug Administration (USA) FNFC: Ministry of Health and Welfare (Foshu, Japan) FSB: Federal Scientific Bodies (USA) JHCI: Joint Health Claims Initiative (UK) NFA: National Food Agency (Fin) SNF: Swedish Nutrition Foundation VC: Voedingscentrum (Nl) WCRF: World Cancer Research Fund WHO: World Health Organisation Encyclopedia of Human Nutrition 2E. Editor-in-chief, Michele J. Sadler, editors, J.J. Strain, Benjamin Caballero. San Diego : Academic Press, c1999. Handbook of Nutrition and Food. Edited by Carolyn D Berdanier...[et al.]. Boca Raton, Fla.: CRC Press, 2002. Introduction to Human Nutrition. Edited on behalf of The Nutrition Society by Michael J. Gibney, Hester H. Vorster and Frans J. Kok. Blackwell Science, September 2002. Title of the study Authors (and their affiliation) Journal or book reference Objective of the study Study type/design If the study type/design is a pooled analysis (systematic review or meta-analysis) of many studies, then include inclusion/exclusion criteria for the studies, and data extraction from the studies Study population (inclusion/exclusion criteria) Baseline characteristics of study subjects and controls Duration of the study Location of the study Methodology (including quality of the active component) Dietary assessment technique Outcome measurement and other relevant measurements Statistics Results Conclusion Points to note/further comments 6 van 10 Entry 6: Examples of Claims Wording Background Examples of wording of health claims that are or could be made on product labels and in advertising and other promotions should be included in the list. The examples should respect the general principles and conditions of the proposed regulation as set out in Articles 3, 5 and 10. The wording explains the nature of the health effect, it gives a proper expectation of the health effect. [?phraseology?] Some examples of wording of claims: Food category, Food or Health relationship food component Calcium Necessary for normal structure of bones and teeth Glucosamine Joint health Ginseng Wholegrain cereals Enhancement of mental and physical capacities in cases of weakness, exhaustion, tiredness and loss of concentration Maintenance of a healthy heart Oats (whole oats, flour, oat bran and rolled oats as sources of soluble fibre, beta-glucan) Reduces total and LDL cholesterol Oily fish (omega-3 PUFA) Maintenance and promotion of a healthy heart 769857186 Example of wording Maintains strong and healthy bones and teeth May help to maintain healthy joints; helps keep joints supple and flexible Helps maintain optimal stamina, feelings of energy and vitality, physical and mental well-being A diet rich in wholegrain foods, as part of a healthy lifestyle, can help maintaining a healthy heart Oats can, as part of a healthy lifestyle, can help reduce cholesterol levels, which in turn helps to maintain a healthy heart Two portions of omega-3 PUFA’s a week helps heart health 7 van 10 2. Classification of scientific data The strength and consistency of the scientific evidence will underpin the “generally acceptance” of the relationship in such a way that the balance of probabilities for the scientific link between a nutrient or substance and a health relationship is justified. As a framework for objective judgement the categorisation scheme from the US Food and Drug Administration Centre for Food Safety and Applied Nutrition will be used as published in the PASSCLAIM report. Established or proposed health effects or nutrient functions were classified as ‘convincing’ in case of consensus or acceptance by official independent scientific bodies, or ‘probable’ if the scientific evidence in support of the effect outweighs the evidence against. In case of contradictory or inconsistent results, or data based upon small studies, or in vitro studies, effects were classified as ‘questionable’. Scheme of scientific substantiation of generic health claims. Single large human study In vitro or animal (laboratory) data only + supportive epidemiological data + contradictory epidemiological data Single small human study Reported Body of consistent, relevant evidence from well designed human study, and/or Epidemiological and laboratory studies. Weight of evidence supportive + supportive laboratory data + contradictory laboratory data + supportive laboratory data Multiple small human studies + consistent results with Small uncontrolled human studies Evidence accepted flawed designs + consistent results with Epidemiological data: consistent results by scientific bodies good designs or independent + contradictory results expert bodies as with good designs + difficulty measuring substance basis for public + biological plausibility and + contradictory laboratory data Reviews by independent expert(s) Epidemiological data: contradictory results 1 emerging evidence health messages Critical reviews by experts consistent laboratory data Meta analyses 2 3 4 5 significant scientific agreement consensus Explanation: Cat. 1 & 2 : insufficient substantiation for generic list, more needed. Cat. 3: “positive outweighs the negative”, one publication of meta-analysis on peer reviewed article category “probable”. Cat. 4 : meta-analysis, peer reviewed publications category “convincing” . Cat. 5: text-handbooks, monographs, judgement by government related organisations, scientific groups or expert organisations (like WHO, SCF etc.) category “convincing”. 769857186 8 van 10 Categories 4 and 5 are translated as “convincing” and can be put on the generic list. Category 3 in this respect is translated as “probable”. These food categories, foods or food components in category 3 will be discussed within the NL working group case by case. Each food category, food or food component in category 3 will be covered by a separate sheet which includes detailed additional information (for the format of this separate sheet see Annex 1). This additional information will be used to determine case by case if the data are convincing enough to put the food category, food or food component on the generic list. For the exact definition of all categories and especially the exact classification of borderline cases, specialist(s) will be asked for advise to help the NL-working group. 769857186 9 van 10 Annex 1 Title of the proposed claim Claim forwarded by For further information contact : ……………………. : ……………………. 1. Nutrient/other substance/food/diet Short description of the nutrient /other substance/food/diet 2. Generally accepted role(s) Describe the role of nutrient /other substance/food/diet w.r.t. its health related function in the sense of article 13. 3. Essential elements of the claim associated with this/these role/roles The proposed wording of the claim(s) is (are): 1. 2. 3. Summary of the grade of evidence underlying the claim(s) : category …. 4. Scientific substantiation (max. of 10 literature references) Nature of evidence - Generally accepted role(s) - Proposed claim(s)(rank according to type of studies (e.g. meta-analysis, expert reviews, human intervention or observational studies, other supporting studies) 5. Summary of the scientific substantiation 6. Indication of the conditions of use, incl. the relevance for the population or target group(s) or individual consumer 769857186 10 van 10