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Meat and Livestock Commission Identifying needs in meat quality research (Defra Reference FO0310) Report 3.2 Difficulties with labelling meat with modified nutritional qualities Based on a knowledge of the legislation and associated guidance and discussions held with stakeholders (2.1), the opportunities and challenges regarding nutrition and health claim labelling of meat with modified nutritional characteristics will be described. The legislation and guidance will be reviewed against the nutritional changes that have been observed with commercially applicable approaches. This will include changes in the legislative framework that could facilitate the promotion of meats with enhanced nutritional properties. The outcome of this element of the project could include an information sheet for industry. Introduction and Background Foods derived from domestic animals are a significant source of nutrients in the UK diet. In addition, certain animal derived foods contain compounds, which may actively promote long-term health. These include two families of polyunsaturated fatty acids (PUFAs): the n-6 (or omega 6) family derived from, linoleic acid (LA), and the n-3 (or omega-3) family derived from alpha (α) -linolenic acid (ALNA). A significant body of evidence continues to accumulate in relation to these fatty acids and potential links with a number of health outcomes, but certain aspects of this remain contentious. However, recognition that the longer chain derivative of ALNA, docosahexaenoic acid (DHA), is a major constituent of human brain and retina has resulted in considerable research particularly in relation to newborn babies. Dietary recommendations and public health policy is based on a sound scientific evidence base. However, detecting associations between nutrition and chronic disease such as cardiovascular disease (CVD) and cancer is not an easy task. Consequently, a number of different approaches need to be taken by researchers, attempting to link dietary factors with disease states. Different approaches have their own strengths and weaknesses but all can collectively contribute to a portfolio of evidence. This accumulation of scientific evidence is and will increasingly become more important for food labelling purposes and in particular in support of the claims that can be made on food. New and evolving food labelling legislation aims to protect the consumer from misleading claims about the health benefits of a food or any of its components. It will become a requirement that unless previously authorised such claims will have to be scientifically substantiated. Research findings will therefore be crucial to the preparation of scientific dossiers in support of any future nutrition and health claims. New EU legislation requires that 1 only approved claims will be allowed to feature on food labels and in advertising. In addition, conditions for using specific claims have been or are in the process of being determined. It will be necessary to monitor the progress of this legislation. Unsaturated Fats Unsaturated fatty acids and their presence in foods has attracted both public and industrial interest. Most fatty acids can be synthesised in the body, but humans lack the enzymes required to produce two fatty acids. These are called the essential fatty acids (EFAs) and must be acquired from the diet. In humans, the essential fatty acids are the n-3 polyunsaturated fatty acid (PUFA) α– linolenic acid (ALNA) and the n-6 PUFA linoleic acid (LA). Although humans can elongate dietary ALNA to the very long chain (VLC) n–3 PUFAs eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the rate of synthesis may not be sufficient to meet requirements (See Appendix One). It is estimated that less than 8% of ALNA is metabolised to EPA, and the capacity for the body to synthesise DHA appears to be particularly limited, with women having a greater capacity for DHA synthesis than men (Burdge & Wooton 2002). In Western diets, n-6 PUFA are the predominant PUFAs. This is in line with current dietary advice to consume a minimum of 1% energy as n-6 PUFAs and 0.2% energy as n-3 PUFAs. The balance of n-3 and n-6 PUFAs has changed substantially, and as the two families share a common metabolic pathway, concern has been raised that this might be detrimental to health. n-3 and n-6 PUFAs have independent health effects in the body, and as intakes of n6 PUFAs are within the guidelines for a healthy diet, concerns about the n-6 to n-3 ratio are driven by low intakes of n-3 rather than high intakes of n-6. Currently in adults n-6 PUFAs contribute to 5.3% energy (see table below). Total daily amount of fat in the diets of adult men and women (amount as percentage of food energy in brackets) Men 86.5 g (35.8%) 32.5 g (13.4%) 2.9 g (1.2%) 29.1 g (12.1%) 2.3 g (1%) 12.9 g (5.4%) Women Total fat 61.4 g (34.9%) SFA 23.3 g (13.2%) Trans-fatty acids 2.0 g (1.2%) MUFA 20.2 g (11.5%) n-3 PUFA 1.7 g (1%) n-6 PUFA 9.4 g (5.3%) Source: Henderson et al. (2003) MUFA, monounsaturated fatty acid; PUFA, polyunsaturated fatty acids; SFA, saturated fatty acid The beneficial effects of the VLC n-3 PUFA in particular EPA (C20:5) and DHA (C22:6) have been well documented and include anti-atherogenic, anti-thrombotic and anti-inflammatory effects and overall, increased intake leads to a reduced risk of coronary heart disease (CHD) (Scientific Advisor Committee on Nutrition (SACN) and the Committee of Toxicology (COT) 2004). It is for these reasons that good sources of the VLC fatty acids, namely oil-rich fish, are recommended to be included in the diet. However, certain aspects of this evidence remain contentious and to 2 make specific dietary recommendation merits further research. The strength of evidence linking dietary fat and risk of chronic diseases is illustrated in the table below. Strength of the evidence linking dietary fat and risk of chronic disease Decreased risk No relationship EPA/DHA; LA ALNA; Oleic acid Stearic acid Increased risk CVD Convincing Probable Possible Type 2 diabetes Probable Possible Cancer Possible C14, 16 SFA C12 SFA n-3 PUFAs SFA Total fat n-3 PUFAs Animal fats Source: WHO/FAO (2003) ALNA, α-linolenic acid; CVD, cardiovascular disease; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; LA, linoleic acid; PUFA, polyunsaturated fatty acid; SFA, saturated fatty acid There is strong supportive, but not yet conclusive evidence that n-3 PUFAs protect against fatal heart disease. This has been suggested in cohort studies (e.g Nurses’ Health study (Hu et al (2002)) intervention trials with fish (e.g DART study (Burr et al 1989)) or intervention with fish oil supplements (e.g. GISSI prevention trail (1999). Manufacturers of products containing pre-defined amounts of the long chain n-3 PUFAs are now able to make scientifically substantiated claims related to a healthy heart, and there is an increasing consumer awareness of the cardiac benefits of including these fatty acids in the diet. However, questions are now being raised as to the amount of these long chain n-3 PUFAs that are required in the diet to gain the most benefit. Beneficial effects observed in secondary prevention trials i.e. those assessing the efficacy of long chain n-3 PUFA supplementation to reduce the risk of a secondary cardiac event in individuals diagnosed with a heart condition, are at levels in the order of 1g per day. In recent years the potential health benefits of ALNA has attracted attention, and evidence is mounting on the role that this n-3 fatty acid may play in preventing the progression of CVD, although it is currently unclear what, if any association exists (Wendland et al 2006). What is becoming clear is that there is a high requirement for DHA in the last trimester of pregnancy and the first three months of life with the foetus and neonate being dependent on a maternal supply of DHA (Al et al 1995). There is some evidence that increased maternal VLC n-3PUFA intake during pregnancy may produce beneficial effects especially in populations that tend to have a lower background intake of VLC n-3 PUFA (Smuts et al 2003) Recommendations Current UK dietary recommendations were derived in 1991 by the Committee on Medical Aspects of Nutrition Policy (COMA). Their report states that the population 3 average for total fat consumption should not exceed 35% of daily food energy intake (or 33% of energy including energy consumed as alcohol). The recommendations on dietary fat are shown below. Recommendations for specific fatty acids were only made for the essential EFAs LA (n-6 PUFA) and ALNA (n-3 PUFA) on the basis of prevention of deficiency, and fat contributed 40% of daily food energy. So in order to achieve the fat intake targets, dietary modification was required (Gregory et al 1990). Adult UK dietary reference values for fat expressed as a percentage of daily total energy intake (food energy in brackets) Individual minimum Population average 10 (11) 6 (6.5) Individual maximum SFA cis-PUFA 10 n-3 0.2 n-6 1.0 MUFA 12 (13) trans-fatty acids 2 (2) Total fat 33 (35) Source: DH (1991) MUFA, monounsaturated fatty acid; PUFA, polyunsaturated fatty acid; SFA, saturated fatty acid. In 1994, the guidelines for intakes of PUFAs were revised to take into account the cardio-protective effects afforded by the long chain n-3 PUFAs. The COMA report advised that there should be no further increase in intakes of n-6 PUFAs as the population target had been achieved, and that the intake of long chain n-3 PUFAs should increase from 0.1 to 0.2g per day (DH 1994) In 2004 the Scientific Advisory Ccommittee on Nutrition (SACN) and the Committee on Toxicology (COT) reviewed their recommendations taking into account the potential toxicological hazards of consuming the recommended levels from oil-rich fish. They noted that the UK population was a high risk one relative to CVD and endorsed the population recommendation to eat at least two portions of fish per week, one of which one should be oil-rich. This is equivalent to 0.45g of VLC n-3 PUFA per day (3.15g/week). The report added that: ‘An increase in population oily fish consumption to one portion a week, from the current levels of about a third of a portion a week, would confer significant public health benefits in terms of reduced risk of cardiovascular disease. There is also evidence that increased fish consumption might have beneficial effects on foetal development.’ It was acknowledged that some groups, especially men and boys could benefit from greater intakes. However, there was a concern about increasing total intakes of oilrich fish to more than 1 portion per week in girls and women of childbearing age because of the potential risk of contaminants present in fish having an adverse effect on subsequent pregnancies, although the safe upper limit from a toxicological point of view was deemed to be 2 portions. 4 Food Standards Agency (FSA) guidelines on fish intake for the UK population (adapted from SACN/COT 2004) Up to 2 portions of oil-rich fish per Week Up to 4 portions of oil-rich fish per week Girls and women who might have a baby one day Other women Women who are pregnant or Breastfeeding Men and boys Fish Consumption Total consumption of fish has declined markedly over the last 50 years (MAFF 2001). The downward trend in fish consumption is primarily a result of reduced intake of white fish rather than oil-rich fish. Henderson et al (2002) showed recently that consumption of oil rich fish has increased from 134g/week to 194g/week by those who consume oil-rich fish. However, only 27% of the UK population are consumers of oil-rich fish (SACN/COT 2004) resulting in a substantial proportion of the population receiving no VLC n-3 PUFA from this source. In addition, it is now clear that in vivo synthesis of EPA and DHA from dietary ALNA is very limited especially in men (Burdge et al 2003) leading to the concept that these VLC fatty acids should now be classified as dietary essential. These facts, together with the increased intake of n-6 fatty acids over the last 20-30years (Saunders 2000), have given rise to concerns that large parts of the UK population may have very substantially suboptimal dietary intakes of VLC n-3 fatty acids. It is this observation that has initiated attention on how intake may be increased by enriching the concentration of EPA and DHA in food of animal origin (Givens 2005). Fat Consumption Trends Since the late 1980’s there has been a downward trend in the total amount of fat in the diet and despite declining energy intakes this has resulted in the percentage energy derived from fat also falling. As a nation we have almost achieved the target recommendation to reduce total fat to no more than 35% of food energy (Henderson 2003). This can be attributed to a number of changes in the key commodity groups that comprise the diet. For example, advances in food processing technologies and animal breeding programmes, as well as modification of animal feeds and modern butchery techniques have all led to a reduction in the total fat content of carcase meat over the past 20-30years. The fat content of carcase meat in the UK has been reduced by over 30% for pork, 15% for beef and 10% for lamb (Higgs, 2000). Fatty Acid Profile of the Diet The fatty acid profile of the diet has also changed considerably over this period. As a population we now consume less saturated fat and derive proportionally more of 5 our energy from unsaturated fatty acids (Henderson 2003). The contribution made by saturated fatty acids to energy intake has fallen significantly compared to the 1980’s from an average of 17% in men to 13.4% and from 16.5% to 13.2% in women. However, as this still exceeds the recommended target of 11% this remains a key focus for Government. Recent attention has also been given to trans fats, even though we are within the population target of <2% of energy (Henderson 2003). Fatty Acid Profile of Red Meat Overall, lean red meat contains similar proportions of MUFAs to SFAs, although as illustrated below the exact proportions vary depending on the type of meat (Chan et al.1995). Typical fatty acid composition (g/100g) of different types of red meat (lean only, cooked) (UK figures) Beef Total SFA 3.26 Total MUFA 3.41 Total PUFA 0.38 n-6 PUFA 0.36 n-3 PUFA 0.09 Source: MAFF (1995) Lamb Pork 5.36 4.06 0.59 0.48 0.23 2.31 2.56 1.15 1.02 0.12 Bacon (grilled) 7.91 8.85 2.71 2.41 0.31 Red meat also contains PUFAs. The predominant PUFAs in meat are LA (n-6) and ALNA (n-3). Although meat contains low levels of PUFAs, in the UK meat and meat products (including poultry) contribute substantially to intakes, providing 18% of n-6 PUFAs and 17% of n-3 PUFAs, whilst contributing to 23% of overall fat intake (Henderson et al. 2003a). There are slight differences between male and female intakes (see table below). Percentage contribution of the main sources of fat intake in the UK adult diet Total fat M F SFA M F trans-PUFA M F MUFA M F n-3 PUFA M F n-6 PUFA M F Cereals & cereal products 19 20 17 19 25 26 17 18 17 16 20 20 Milk & milk products 14 15 23 25 15 16 9 11 4 4 2 3 Fat spreads 12 11 12 11 19 17 12 11 7 6 15 12 Meat & meat products 25 20 25 19 23 18 30 24 19 14 20 16 Fish & fish dishes 3 4 2 2 3 3 3 4 13 16 4 5 Potatoes & savoury snacks 10 10 7 7 7 6 11 12 17 16 13 13 Source: Henderson et al. (2002) 6 M, male; F, female; MUFA, monounsaturated fatty acid; PUFA, polyunsaturated fatty acid; SFA, saturated fatty acid Meat also contains small amounts of the long-chain n-3 PUFAs EPA and DPA (Wood et al. 1999). Some EPA can be produced from the precursor ALNA, but as previously stated conversion rates are low and further conversion to DHA is very limited (Givens, 2005). However, although only a small amount of these VLC n-3 PUFAs are found in meat, as there are few rich sources apart from oil-rich fish, meat can usefully contribute to intakes of these important fatty acids for those who consume little or no oil-rich fish (Higgs, 2000; BNF 1999). The table below illustrates a comparison of the fatty acid content of meat, milk and fish (MAFF 1998). The unsaturated fatty acid composition of lean, raw meat, cow’s milk and raw, fresh fish (g fatty acids/100 g) Total fat (g/100g) MUFA (g/100g) 14:1 16:1 18:1 Oleic 18:2 LA PUFA (g/100g) 18:3 20:4 20:5 ALNA AA EPA 22:6 DHA Beef Lamb Pork Chicken 4.3 8.0 4.0 3.7 0.02 0.01 0 0 0.15 0.13 0.09 0.04 1.54 2.37 1.36 0.42 0.11 0.13 0.54 0.16 0.03 0.09 0.05 0.02 0.02 0.02 0.04 0.01 0.01 0.02 0.01 tr 0 0.01 0.01 0.01 Whole milk Semiskimmed Skimmed 4.0 0.04 0.07 0.80 0.07 0.02 0 0 0 1.7 0.02 0 0.34 0.03 0.01 0 0 0 0.3 0 tr 0.06 0.01 tr 0 0 0 Cod Herring Salmon Mackerel 0.7 13.2 6.3 16.1 0 0.01 n/a 0 0.01 1.06 0.25 0.59 0.05 1.50 1.35 1.91 Tr 0.29 0.17 0.30 tr 0.18 0.30 0.22 0.02 0.04 0.27 0.07 0.08 0.51 0.32 0.71 0.06 0.69 1.12 1.10 Source: MAFF (1998) AA, arachidonic acid; ALNA, α-linolenic acid; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; LA, linoleic acid; MUFA, monounsaturated fatty acid; PUFA, polyunsaturated fatty acid; tr, trace Enhancing the Fatty Acid Profile of Meat The fatty acid profile of non-ruminant meat is essentially a reflection of that in the diet (Givens & Shingfield, 2004). For example, in mono-gastric animals such as pigs, inclusion of vegetable and fish oils in feeds has resulted in significant increases in n3 PUFA, particularly when compared to a traditional cereal based diet, with the meat fat principally comprising SFAs and MUFAs. In ruminants, the composition of fat is less variable and it has been more difficult to modify the fatty acid profile of the meat, owing to the influence of gut bacteria (Higgs, 2000). Meat from ruminants fed on grass throughout the year has higher levels of PUFAs. This is because a small proportion of the major fatty acid in grass, ALNA, can escape hydrogenation in the rumen, and is absorbed into the tissue lipids. Meat will also provide long-chain n-3 PUFAs as a result of the transformation of dietary ALNA to EPA and DHA. 7 Oil seeds such as linseed and rapeseed are also high in ALNA, and therefore meat of animals reared on feeds containing these will also contain higher levels of n- 3 PUFAs (primarily ALNA) (Givens 2005). It is hoped that the development and use of these feeds will not only increase the concentration of the long chain n-3 PUFAs in meat but that it will ultimately enhance human health (Nugent 2005). It has been estimated that the average intake of long chain n-3 PUFA, of the UK adult population is approximately 244mg per day (Givens & Gibb 2006). However, as oil–rich fish contributes about 131mg per day of this total, and as only about 27% of the UK population consume any oil-rich fish, average intakes for the vast majority of the population may be as low as 113mg per day. For those who consume little or no fish, the intake could be as low as 43mg per day, with poultry being a key supplier. These estimates are considerably short of the recommended 450mg of long chain n-3 PUFA per day, and there is therefore much scope for dietary change. The degree to which nutritionally enhanced animal foods can make a significant contribution to making such dietary changes remains to be fully assessed. Human intervention studies are sadly lacking as is evidence of the bioavailability of n-3 PUFAs from foods from animal origin. In addition, certain aspects of some animalderived foods, notably levels of saturated fatty acids, continue to give rise to concerns that these foods may contribute to the risk of cardiovascular disease, the metabolic syndrome and other conditions (FSA 2007). Even with the reductions in fat content of red meat and dairy produce over the years the remaining proportion of saturated fat could continue to place restrictions on the promotion of these animal derived foods by evolving labelling regulations. Lipgene The development of nutritional strategies for the production of animal products with enhanced nutritional characteristics is an important component of the Lipgene Project. This is an integrated project within the EU funded Sixth Framework research programme. The main aim of Lipgene is to investigate the interaction between dietary fat composition and genotype in the development of the metabolic syndrome in humans. The project recognises that the future role of animal nutrition in creating foods closer to optimum composition for long term health will become increasingly much more important. However, this work is currently confined to the production of improved milk and poultry (www.nutrition.org.uk/lipgene). Promoting Nutritionally Enhanced Meat Today consumers are increasingly exposed to a wide variety of messages about the relationship between diet and health and there is widespread interest in the nutritional content of all food including meat and meat products. Information about nutrition and health in the press can appear complex or conflicting and it may not be clear to many consumers what the healthiest choice is when deciding which foods to buy (IGD 2007). Clear labelling of food with nutritional information is seen as a supportive means to assist the consumer on making informed choice. It is viewed as an educational tool and there has been increasing pressure on food manufacturers to make it clearer and more ‘consumer friendly’ (www.food.gov.uk/foodlabelling). 8 Government, retailers and other food business operators (FBOs) are collectively behind moves to produce clearer food labelling and a number of initiatives are currently being pursued to assist the customer in making healthier food choices. This includes front of pack labelling schemes. Several different executions of front of pack labelling schemes are currently in use in the UK. Some adopt the FSAs ‘traffic light’ approach, which categorises fat, saturated fat, sugar and salt content. Others use Guideline Daily Amounts (GDAs) indicting the contribution a portion of a particular food makes to GDAs for energy, fat, saturated fat, carbohydrate, sugar, fibre and sodium. Others use a combination of these approaches, but all have in common the aim of having a positive impact on consumer food choice. Unsaturated fatty acids will contribute to the total fat figure used for front of pack labelling purposes and therefore are not directly communicated to consumers by any of these schemes. They thus contribute to the negative impression of total fat content and any positive message is lost. There is considerable debate about these various promotional devices and the degree to which they impact on consumer purchase behaviour. The FSA is currently in the process of commissioning research into the effectiveness of the various front of pack labelling schemes. Running in parallel with this is an evolving regulatory framework determining what should and should not feature on food labels particularly with regard to nutrition and health claims. Food Labelling Currently it is not mandatory to include information about the nutrient content on a food item unless the producer or manufacturers, wishes to make a nutrition claim. Although labelling is voluntary, the format of nutrition labelling on pre-packed foods is dictated by law and must take one of two formats, which will be described. In the UK the Food Labelling Regulations (FLR)1996 (Statutory Instrument 1996 No. 1499) cover all statutory information that must appear on food packaging including nutrition labelling. This legislation covers all pre-packed food and to some extent other foods for sale in the UK e.g. for catering, in-store bakery, etc. It can be accessed at http://www.opsi.gov.uk/si/si1996/Uksi_19961499_en_1.htm These regulations dictate that nutrition labelling on pre-packed foods must take one of two formats. The minimum amount of information that can be declared on a label is termed a group 1 declaration (which lists the energy, protein, carbohydrate and fat content of a food per 100g or per 100ml; nutrition information may also be provided on a per serving basis). Further information can be included in the form of a group 2 declaration, which lists group 1 nutrients plus sugars, saturates, fibre and sodium. (see table below). 9 An example of a group 2 nutrition information panel NUTRITION INFORMATION Energy Protein Carbohydrate (of which sugars) Fat (of which saturates) Sodium Fibre Per 47g 689kJ 163kcal 4.7g 26.9g 3.1g 4.1g 0.6g 0.2g 7.8g Per 100g 1466kJ 347kcal 10g 57.2g 6.6g 8.7g 1.3g 0.4g 16.6g MUFAs and PUFAs may also be declared within a food label, but only if the SFA content is also declared. This would therefore require a group 2 declaration. Information on any other nutrient must be provided if a claim has been made about it and if labelling regulations permit its inclusion in the nutrition panel. Joint Health Claims Initiative Currently there are no regulations in the UK regarding whether food manufacturers may claim that a food is a source of, or rich in unsaturated fatty acids. However, the Joint Health Claims Initiative (JCHI)1 having assessed the scientific data relating to long chain n-3 PUFAs and Coronary Heart Disease (CHD), approved the use of a generic health claim, relating to the long chain n-3 PUFAs (EPA, docosapentaenoic acid (DPA), and DHA) on pre-packaged foods and associated advertising material. The following statement is permitted as long as the food provides at least 0.2g of long chain n-3 PUFAs per serving. ‘eating 3g weekly , or 0.45g daily, long chain omega-3 PUFAs, as part of a healthy lifestyle, helps maintain heart health’ However, other conditions must also be met which preclude the authorisation of this claim on meat, even with enhanced nutritional profile with regard to n-3 PUFAs. The claim relates only to very long chain PUFAs (of chain length 20 carbons or above) including EPA, DPA and DHA (i.e. 20:3n-3, 20:4n-3, 20:5n-3, 22:5n-3 and 22:6n-3), and not all long chain PUFAs, such as alpha-linolenic acid (i.e.18:3n-3 and 18:4n-3). In addition the ratio of EPA and DHA should reflect that which occurs naturally in oily fish. In addition, products carrying the claim should include the statement: 1 The JHCI is a joint venture between consumer organisations, enforcement authorities and industry trade associations in the UK to establish a Code of practice for health claims on food. The Code is not seeking to replace food legislation; instead it was established in the absence of legislation in an attempt to provide effective consumer protection and consistency in the use of health claims in the UK. 10 ‘The Government advises that at least 2 servings of fish, one of which should be oily, containing approximately 3g LC N –3 PUFA, is consumed each week.’ Although the JHCI no longer operates, the work that they did is still useful to producers and manufacturers. Their list of generally accepted nutrient function claims can be found on their website http://www.jhci.co.uk/ Canadian regulatory definitions of the fatty acids that constitute ‘omega –3’ include ALNA (C18:3), arachindonic acid (C20:4), EPA (C20:4) DPA (C22:5) and DHA (C22:6) (www.nutritionlabels.ca). For the purposes of labelling in Canada it is the total sum of these five fatty acids that is used. Nutrition and Health Claims A new European Regulation (regulation (EC) No 1924/2006) has been introduced which will place restrictions on they type and nature of nutrition and health claims that can be made by the food industry in their labelling, advertising and presentation of food sold direct to consumers; as well as to foods supplied to mass caterers, including restaurants, hospitals and schools. It can be accessed at http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1924R9(01):EN:HTML It recognises that a growing number of foods now carry nutrition and health claims and the new regulation attempts to harmonise the way these are made across the EU. The aim of this regulation is to put together a list of permitted nutrition and health claims that can be used by manufacturers across the EU by January 2010. Overall, any claim made should be truthful and should not attempt to mislead consumers. Nor should it call into question the safety or nutritional content of other foods or the adequacy of a balanced diet. Three types of claim will be allowed to be made on foods throughout the European Union: nutrition claims, health claims and disease risk factor reduction claims. The latter are a specific type of health claim, which state that a food or one of its components significantly reduces a risk factor for human disease. For example, phytosterols can help reduce blood cholesterol, hereby reducing a risk factor for CVD. This means that for the first time, mention of disease will be allowed on food, but only after approval by the European Food Safety Authority (EFSA). Nutrition Claims Nutrition claims, which state, suggest or imply that a food has particular beneficial properties due to its composition (regarding energy or a particular nutrient). Examples of this type of claim will be: ‘source of’, ‘free of’, ‘high’, ‘low’ or ‘reduced’ in calories or a particular nutrient. A nutrition claim states or suggests that a food has particular beneficial nutritional properties. For a company wishing to make a nutrition claim on their product, the specific claim must be listed in the Annex to the regulation. Examples listed in the Annex include ‘low fat’, no added sugars, ‘high fibre’ and ‘source of calcium’. In each case, conditions are specified for each claim, for example, foods claiming to be ‘low fat’ must have no more than 3g fat per 100g. 11 For a food to be a source of a vitamin and/or mineral it must contain, as a minimum, a significant amount of the micronutrient, i.e. 15 % of the recommended daily amount (RDA). For a food to be high in a vitamin and/or mineral (or any claim likely to have the same meaning), the food must have twice the value of a ‘source’ i.e. 30% RDA. Conditions also apply to the use of the word ‘contains’ and ‘increased’ when applied to a particular nutrient. The claim ‘contains’ requires fulfilment of the conditions for ‘source of’ i.e. 15% of RDA. ‘Increased’ in content requires to be at least 30% increased compared to a similar product and it must meet the conditions for a ‘source’ claim. Presently no RDA exists for n-3 fatty acids but the Reference Nutrient Intake (RNI) is 2grams per day. The EC requested EFSA to issue an opinion of the scientific substantiation of nutrition claims relating to unsaturated fats and advise on their addition to the Annex of the Regulation (Request No EFSA-Q-2004-107). Concern was raised about the anomalies that would arise when applied to certain foods and the meaning these claims would have to the consumer. For these reasons the Annex does not presently include provision for claims relating to unsaturated fat. Provision for Omega –3 Fatty Acid Claims In its current format the Annex is not an exhaustive list, and it is recognised that there are key omissions. Discussions are currently underway with EFSA about the provision for omega-3 fatty acids claims and a number of claim options are under consideration (see Appendix 2). The EFSA have put forward several arguments as to why they suggest that these claims should be used in relation to ‘per 100g’ or ‘100ml’ or ‘100kcal’ of product. Reference to 100kcal would not allow high water content products such as vegetables to bear the "source of omega 3" claim as the general conditions require that claims should take account of the quantity of product that can reasonably expected to be consumed. It also means that while rapeseed, soybean and linseed oils would qualify for the claims on omega-3 fatty acids, certain blends of vegetable oils would not. Blends of sunflower oil with rapeseed or soybean oils are widely used to introduce omega-3 fatty acids in countries where traditionally no omega-3 oils are consumed (e.g. Portugal, Hungary, Romania). For various reasons (unpleasant smell when frying or cooking or national standard, e.g. in Portugal), the amount of rapeseed/soybean oil in these blends is often limited to ±20 %, which means ±2g of omega-3 fatty acids/100 g product. These blends currently have claims on omega-3 fatty acids, but would not be authorised in the future with the new proposed conditions (see Appendix 2). Other higher energy foods that contain more than 100kcal per 100g would also be prevented from making claims. This is true for many products including red meat and dairy produce. Cheese and butter are very good carriers of omega 3 fatty acids, and omega 3 enriched milks, cheeses and butters are currently sold on the European market. This is especially seen in Southern Europe, providing a significant part of the omega 3 contribution to the diet in countries such as Spain, France and Italy. 12 EFSA maintain that it has taken into account that higher energy foods are often not eaten in big quantities. For example, the average daily intake of cheese is around 30g, which can provide a significant amount of omega 3. However, with a reference to 100kcal, this claim will not be allowed, not even for low fat cheeses. In light of these discussion it is therefore very likely that the Annex will be subject to change and additional content claims for example, relating to omega-3 fatty acids may be added as the legislation matures. However, the conditions set for making these claims may continue to prevent red meat and dairy products with enhanced fatty acid profiles from making use of these claims. Health Claims Health claims, state, suggest or imply that a relationship exists between a food or one of its components and health. This type of claim mentions the physiological function of a constituent such as ‘calcium can help build strong bones’. The claim must be based on generally accepted scientific data and be well understood by the average consumer. A health claim is any statement used on labels in marketing or in advertising that directly states or implies that health benefits can result from consuming a given food or from one of its constituents. Hence advertising two pork chops placed together in the shape of a heart would be considered to be an implied health claim. Thus claims relating to an enhanced unsaturated fat profile of meat could be considered a health claim requiring substantiation. The assessment made by JHCI specifies the conditions for using a generic n-3 health claim and these currently preclude its application to nutritionally enhanced meat. A further condition made in the new regulation requires products making a health claim to display a message on the importance of a varied, balanced diet and healthy lifestyle, and provide information about the amount and frequency of consumption required to get the claimed health benefit. In addition, such claims would be viewed as disease risk reduction claims which in the past were not allowed. However, under the new regulations disease risk reduction claims will be permitted but only if capable of being substantiated by scientific evidence. FSA Dossier of Claims Approval for the use of claims will be achieved in the first instance by establishing a positive list of claims. This will be generated in three steps. Member States will first send the list of the claims they consider are valid, based on generally accepted science in their country. Earlier in 2007 the FSA requested submission of dossiers listing claims based on generally ‘accepted scientific evidence’ in order to compile a UK list of approved claims. A dossier was submitted by the MLC listing the generic nutrient/health claims 13 relating to red meat. An example of a claim based on generally accepted scientific evidence would be; iron helps make red blood cells, which carry oxygen around the body. Approval of these claims will also be based on consideration that they be well understood by the majority of consumers. The current scientific evidence only supports the inclusion of one claim on n-3 fatty acids in the submitted dossier. This relates to brain development in the foetus. The wording submitted is as follows; long chain n-3 fatty acids play an important part in the development of a baby’s brain while in the womb. The conditions for using the claim being that each serving must contain no less than 0.2g long chain n-3 PUFA (i.e. lower than proposed by EFSA). This claim is supported by evidence from publications by the Department of Health and British Nutrition Foundation (BNF). Depending on feedback the only possibility of this claim being applied to nutritionally enhanced meat would be if the condition for using the claim could be altered. However, given the current EFSA proposals this perhaps seems ambitious. When the FSA finalise their list along with references providing scientific justification it will be submitted to the Commission for consideration by the end of January 2008. Then EFSA will evaluate those claims received and a final accepted list of claims will be in the public register, but this is not expected to be available until January 2010. Authorisation of Health Claims On the 16th of May the EFSA opened a consultation on its draft Scientific Technical Guidance for the Preparation and presentation of the Application for Authorisation of a health claim (www.efsa.europa.eu.en/press_room/press_release/pr_nda_guidance_health_claim s.html .), which includes claims based on proprietary data for which applicants will enjoy a five-year period of exclusive use. The consultation closed on 17 June. The EFSA is yet to publish details about how they intend to weigh the evidence, which is a requirement of the Regulation. Any new claims will have to be submitted for approval supported by scientific dossier supporting the claim as previously discussed. This is likely to be a costly process and one that will preclude small and medium sized companies. It is estimated that this would cost in the region of £15,000 (FSA) not including any investment in supporting research. For disease risk factor reduction claims and claims on children’s health, more elaborate procedures have been foreseen. There is currently no transition period for disease risk reduction claims as they are currently illegal in most European Member States. However, children’s claims are currently abundant on the UK market and a revision of the legislation is currently being sought in order to permit the smooth transition of the legislation. The UK FSA is currently writing a guidance note for this legislation and their aim is to break each article in the regulation down and give simple explanations to the food industry (www,food.gov). 14 Food Composition and Claims In order to make nutrition claims that comply with the conditions in the Annex it is essential to know the amount of the nutrient in question in the food or drink. This highlights the necessity of accurate food composition data. As laboratory analysis of food composition is unfeasible for many companies, food composition databases are relied upon for this data. The importance of this has been recognised by the EuroFIR (European Food Information Resource Network) Project (www.eurofir.net). This is a world-leading European Network of Excellence on food composition databank systems, which aims to provide an internet portal which will allow access to the most up to date food composition data. The food industry is being actively encouraged to participate with this project by contributing product specific data. In addition, for the first time it is expected that Eurofir will give recognition to the importance of the bioavailability of nutrients and hence their utilisation by the body. This will open the need for further research in this area Nutrient Advertising Profiles Claims are used to present products as having an additional health or nutritional benefit. In most cases, consumers perceive products carrying certain claims to be better for their health and wellbeing (IGD 2007). However, at the moment, a food that is high in fat, salt and/or sugar, can still use claims such as “rich in vitamin C” or “high in fibre”, even if the overall health and nutritional benefits of the product are low. The Regulation requires the European Commission to establish nutrient profiles as criteria that foods must meet to bear claims. The nutrient profiles will be based on the scientific opinion of the EFSA. Within 24 months of the Regulation entering into force, the Commission will consult the relevant stakeholders, and present proposals for nutrient profiles to Member State experts. If they support these proposed nutrient profiles, they will be adopted by the Commission and used as a condition for making claims. In order to facilitate the application of this measure, a derogation (exemption) was agreed which will allow nutrition claims to be made if just one nutrient is higher than the required profile. However, the high level of this nutrient must be clearly marked on the label, close to and with the same prominence as the claim. If two or more of the nutrients exceed the limit, no nutritional claim can be made. Such a system of nutrient profiling will be used in conjunction with this regulation to ensure that claims do not mask the overall nutrient content of a product. It is hoped that this will encourage manufacturers to improve the nutritional characteristics of their products, making it easier for consumers to choose a healthy balanced diet. However, the degree to which this goal will be successfully achieved will largely depend on the characteristics of the model developed. The EFSA has been asked by the Commission to provide scientific advice on constructing nutrient profiles and a number of options are currently being considered. These include; 15 Should the profile be set for all foods across the board or should it be applied differently to different categories of food? What selection of nutrient should be taken into account? What quantity of a product should the profile be based on? How should the profile of nutrients be quantified? threshold values or scoring systems The end result will have to take into account the complex relationship between diet, nutrition and health. It will need to be user-friendly for stakeholders, such as food business operators and regulators and crucially it will have to take into consideration the commercial, cultural and culinary aspects of food. The development and application of nutrient profiles will have a major impact on the advertising and promotion of all foods, including that of generic commodity groups such as red meat, poultry and milk and products made from them. Future research programmes aiming to enhance the nutritional profile of meat and milk will need to observe the significance of this. However, it is equally important that this device for controlling advertising does not undermine the importance of research in this area as the potential public health impact could be significant. Conclusion A significant amount of evidence has accumulated about the link between dietary fat and health. It is now generally accepted that saturated fat increases risk of chronic diseases such as CVD. Evidence about the positive health benefits of essential fatty acids such as omega-3 PUFAs continues to accumulate, but aspects of this remain contentious and it may be that only supplements can deliver the quantity needed to gain specific health benefits. The strongest evidence supports the importance of these fatty acids for foetal brain development linked in particular with the VLA PUFAs. Some evidence supports the potential health benefit of ALNA in preventing the progression of CVD but it is unclear what, if any association exists. Despite this, consumer awareness about the importance of these fatty acids is fragmented and is largely driven by the recommendation to consume oil-rich fish twice a week. Consumers are increasingly exposed to a wide variety of messages about the relationship between diet and health and this can appear complex or conflicting. Various initiatives are currently underway to assist consumers in making healthier food choices. Some of these relate to the way food is labelled. Running in parallel with these is an evolving regulatory framework, which will place restrictions on the type and nature of nutrition and health claims that can be made by the food industry. This legislation aims to harmonise claims made across the EU by developing a list of permitted claims and conditions for their use. The present Annex to the legislation lists approved claims and conditions for use but does not include n-3 fatty acid claims. This is currently under consideration but the conditions for use and or the prospect of applying nutrient profiles to foods permitted to carry claims, could 16 continue to prevent foods from animal origin with enhanced nutritional characteristics from highlighting this on labels or in any other promotional material. References AI MDM, van Harwelingene AC & Harnstra Cr (1995) Long chain polyunsaturated fatty acids, pregnancy and pregnancy outcome. 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Proceedings in the Nutrition Society 58:363-70. 20 APPENDIX 1 METABOLISM OF ESSENTIAL FATTY ACIDS (adapted from Napier & Sayanova 2005) 9Desaturase Pathway 18:2n-6 Linoleic acid (from the diet) 9-elongase 6-Desaturase Pathway 18:2n-6 Linoleic acid (from the diet) 18:3n-3 α-linolenic acid (from the diet) 6-desaturase 6-desaturase 18:4n-3 20:2n-6 Eicosadienoic acid 8-desaturase 18:3n-6 -Linolenic acid 6-elongase Octadecatertraen oic acid 6-elongase 20:4n-3 Eicosatertraenoic acid 5-desaturase 20:3n-6 Dihomo-- 5-desaturase 20:4n-6 Arachidonic acid 20:3n-6 Dihomo-Linolenic acid 5-desaturase 20:4n-6 Arachidonic acid 20:5n-3 Eicosapentaenoic acid (EPA) ‘Sprecher’ Pathway 5-elongase 22:5n-3 Docosapentaenoic acid (DPA) 24:5n-3 Tetracosapentaenoic acid 7-elongase 4-desaturase 6-desaturase 24:6n-3 Tetracosahexaenoic acid Peroxisomal β-oxidation 22:6n-3 Docosahexaenoic acid (DHA) 22:6n-3 Docosahexaenoic acid (DHA) 21 Appendix 2 List of n-3 fatty acid claims SOURCE OF OMEGA 3 FATTY ACIDS: A claim that a food is a source in omega 3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where at least one of the following conditions are met: - Minimum 0.3g alpha-linolenic acid per 100g or 100ml or 100kcal product - Minimum 30mg very long chain omega 3 fatty acids per 100g or 100ml or 100kcal product HIGH OMEGA 3 FATTY ACIDS: A claim that a food is high in omega 3, fatty acids and any claim likely to have the same meaning for the consumer, may only be made where at least one of the following conditions are met: - Minimum 0.6g alpha-linolenic acid per 100g or 100ml or 100kcal product - Minimum 60mg very long chain omega 3 fatty acids per 100g or 100ml or 100kcal product SOURCE OF OMEGA 6 A claim that a food is a source in omega 6 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where the following condition is met: - Minimum 2.1g linoleic acid per 100g or 100ml or 100kcal product HIGH IN OMEGA 6 A claim that a food is high in omega 6 fatty acids and any claim likely to have the same meaning for the consumer, may only be made where the following condition is met: - Minimum 4.2g linoleic acid per 100g or 100ml or 100kcal product OPTIMAL RATIO OMEGA-6/OMEGA-3 FATTY ACIDS A claim that a food has an optimal ratio of Omega-6/Omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may be made as long as the following conditions are met: - Omega 6:Omega 3 is equal or lower than 5; - Be at least source of Omega 3 (minimum 0.3g α-linolenic acid per 100g or 100ml or 100kcal product of the product or minimum 30mg long chain omega 3 per 100g or 100ml or 100kcal product of the product) 22