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Authorised EU health claim for foods with a low or reduced content of saturated fatty acids
Authorised EU health claim for foods with a low or reduced content of saturated fatty acids
14
K.M. Livingstone Newcastle University, Newcastle upon Tyne, UK
14.1
Introduction
This chapter will evaluate the European Union (EU) approved health claim related to foods with low or reduced amounts of saturated fatty acids (SFAs) and maintenance of normal blood LDL-cholesterol concentrations, that was reviewed by the European Food Safety Authority (EFSA) in 2011 (EFSA, 2011). The characterisation of the food constituent, the scientific substantiation for the health claim and the conditions of use will be defined and evaluated. The wider impact of this claim will be discussed in relation to consumer issues, product development and future trends.
14.2
Characterisation of the substance
The constituents subject to characterisation were mixtures of SFAs as present in foods. EFSA (2011) concluded that SFAs were sufficiently characterised and the definition is summarised here: ‘Saturated fatty acids are aliphatic monocarboxylic acids with (generally) an even number of carbon atoms (usually from 4 to 20) and no double bonds, that can be liberated by hydrolysis of triacylglycerols from fats and oils. The most prevailing SFAs in the diet are lauric acid (12:0), myristic acid (14:0), palmitic acid (16:0) and stearic acid (18:0)’ (EFSA, 2011). See Figure 14.1.
14.3
Authorised EU health claim: low or reduced SFAs
The EFSA Panel on Dietetic Products, Nutrition and Allergies evaluated the scientific substantiation for the health claim relating to foods with low or reduced amounts of SFAs and maintenance of normal blood LDL-cholesterol concentrations. As an integral step in this evaluation, the wording of the claim and the conditions of use were defined.
Foods, Nutrients and Food Ingredients with Authorised EU Health Claims. http://dx.doi.org/10.1016/B978-1-78242-382-9.00014-1 © 2015 Elsevier Ltd. All rights reserved.
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O OH
Figure 14.1 Structure of the saturated fatty acid stearic acid.
14.3.1 Claim wording The proposed wording as defined by EFSA was as follows: ‘Consumption of saturated fat increases blood cholesterol concentrations; consumption of foods with reduced amounts of saturated fat may help to maintain normal blood cholesterol concentrations’ (EFSA, 2011). As a result, further to the authorisation procedures, the approved wording for use as a health claim was specified: ‘Reducing consumption of saturated fat contributes to the maintenance of normal blood cholesterol levels’ (EU register of claims: http://ec.europa.eu/nuhclaims).
14.3.2 Conditions of use In order to bear the health claim in question, the panel specified that the product should contain low or reduced amounts of SFAs, as per the Annex of the Regulation (EC) No. 1924/2006 (EU, 2006), and be in accordance with the guidance on the implementation of Regulation (EC) No. 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods. The given claim relates to foods with a low or reduced content of SFAs. As such, the conditions of the nutrition claims ‘LOW SATURATED FAT’ and ‘REDUCED’ should be met in order to make this health claim (http://ec.europa.eu/nuhclaims). As per the Annex of the Regulation (EC) No. 1924/2006, to claim that a food is low in SFAs, the sum of SFAs and trans-FAs in the product should not exceed 1.5 g/100 g for solids (or 0.75 g/100 ml for liquids), and the sum of SFAs and trans-FAs must not provide more than 10% of energy. Alternatively, if the conditions for the nutrition claim of reduced SFAs are satisfied, then the reduction in content of SFAs must be at least 30% compared to a similar product (EU, 2006).
14.3.3 Summary of substantiating evidence The recent scientific opinion, published by the EFSA panel, evaluated the scientific substantiation for the health claim relating to foods with low or reduced amounts of SFAs and the maintenance of normal LDL cholesterol. This report highlighted that the totality of the evidence supported a positive relationship between consumption of mixtures of SFAs, as present in foods, and total and LDL cholesterol, relative to carbohydrates, cis-MUFAs and cis-PUFAs. Although EFSA acknowledged the evidence relating to the differential effect of individual SFAs, including lauric, myristic, palmitic, stearic and short- and medium-chain SFAs (4–10 carbon atoms) on cholesterol concentrations, the mixture of these SFAs, as found in the diet, was the primary focus of the report. The following section will summarise and evaluate the main sources of
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scientific evidence used to substantiate the claimed effect between SFAs and cholesterol concentrations. The full list of supporting references provided to EFSA is available on the EFSA Website (EFSA, 2012).
14.3.3.1 EFSA opinions EFSA has published a number of opinions relating to SFAs and health. In 2004, the EFSA panel published an opinion on the effects of trans-FAs on human health (EFSA, 2004). Within this report, the parallels between the effects of trans-FAs and SFAs on LDL-cholesterol concentrations were investigated. Significantly, the meta-analysis by Mensink et al. (2003), as reviewed in Section 14.3.3.2, was cited as a main source of evidence for a detrimental effect of trans-FA on LDL and HDL cholesterol. As reported by Mensink et al. (2003), when 1% of energy in the diet from carbohydrates was replaced isoenergetically by trans-FA, LDL cholesterol was raised by as much as 0.040 mmol/L. Similarly, when the evidence for individual SFAs was collated, palmitic (+0.039 mmol/L), lauric (+0.052 mmol/L) and myristic acid (+0.048 mmol/L) also increased LDL cholesterol. Based on an evaluation of the scientific literature and current country-specific recommendations, the EFSA panel published a scientific opinion on the dietary reference values for fat (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2010). This report provided a review of the physiological role of fat, current European-wide levels of intake and a summary of country-specific recommendations for fat intake. With regard to SFAs, recommendations were set as follows: 10% total energy by the German-Austrian-Swiss authority (DACH, 2008), the UK Committee on Medical Aspects of Food Policy (Department of Health, 1991), the Health Council of the Netherlands (GR, 2001) and the Dietary Guidelines for Americans (HHS/USDA, 2005); and 8% energy from SFAs by the Nutritional Recommendations for the French Population (AFSSA, 2001). As substantiating evidence for setting EFSA-based dietary reference values, the effect of SFAs on cholesterol was reviewed, with reference to a number of metaanalyses (Gardner and Kraemer, 1995; Clarke et al., 1997; Howell et al., 1997; KrisEtherton and Yu, 1997; Mensink et al., 2003; Mozaffarian et al., 2006). Although EFSA declared that there was ‘wide consensus’ that SFAs raised total, LDL and HDL cholesterol relative to carbohydrates, it should be noted that data from two of the metaanalyses, Mensink et al. (2003) and Mozaffarian et al. (2006), differed in their estimation of the effect of SFAs based on their choice of reference group. While the former compared the effect of replacing carbohydrates with SFAs, cis-MUFAs, cisPUFAs and trans-MUFAs, the latter quantified the effect of replacing SFAs, cisMUFAs and cis-PUFAs, with trans-FAs. Nonetheless, the formulae utilised by Mozaffarian et al. (2006) were based on the methods previously used by Mensink et al. (2003). As reviewed by Givens (2008), the formulae devised by Mensink et al. (2003) can be rearranged to yield similar predicted changes in cholesterol concentrations when SFAs are replaced with either cis-MUFAs, cis-PUFAs or trans-FAs, thereby showing comparability between meta-analyses. Both meta-analyses were in agreement with respect to the LDL-cholesterol raising effect of SFAs and trans-MUFAs, compared
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with cis-MUFAs and cis-PUFAs, with SFAs being less detrimental to cholesterol levels than trans-MUFAs due to their ability to increase HDL-cholesterol concentrations. Based on this evidence, EFSA recommended that intakes of SFAs be as low as possible.
14.3.3.2 Randomised controlled trials
0.05
0.03 0.02 0.01 0 −0.01 −0.02 −0.03 −0.04
—
—
Cholesterol (mmol/L)
Total: HDL cholesterol
In addition to EFSA opinions, the panel based a large proportion of its decision on the strength of evidence for the given claim on results from randomised controlled trials. Specifically, quantitative summaries in the scientific literature, in the form of metaanalyses, were also included. Mensink et al. (2003) combined data on consumption of classes of FAs and individual FAs, from 60 studies, including 1672 individuals, in order to calculate the changes in total, LDL and HDL cholesterol and the total-toHDL-cholesterol ratio. Studies were only included if food intake was thoroughly controlled, and if parallel, crossover, or Latin square designs were used. Studies were also only included if feeding periods were longer than 13 days, and if adults did not have disturbances of lipid metabolism or diabetes. Comparison of replacement of 1% energy from carbohydrates with SFAs, cis-MUFAs, trans-MUFAs and cis-PUFAs (excluding long-chain n-3 PUFAs) indicated that both HDL and LDL cholesterol significantly increased. Critically, HDL and LDL cholesterol significantly increased and decreased, respectively, after replacement of SFAs with cis-MUFAs and cis-PUFAs. Furthermore, HDL and LDL cholesterol significantly decreased and increased, respectively, with trans-MUFA intake. Subsequently, there was a non-significant increase in the totalto-HDL-cholesterol ratio with SFAs, a significant increase in this ratio when replaced with trans-MUFAs and a decrease when replaced with cis-MUFAs and cis-PUFAs (see Figure 14.2). In addition to mixtures of SFAs, Mensink et al. (2003) also investigated the effects of individual FAs – lauric, myristic, palmitic and stearic acids – on cholesterol concentrations. Results confirmed that when 1% energy from carbohydrates was isoenergetically
Saturated Mono unsaturated Poly unsaturated trans
0.04 0.03 0.02 0.01 0 −0.01 −0.02 −0.03 HDL Saturated
Mono unsaturated
LDL Poly unsaturated
trans
Figure 14.2 Predicted changes (△) in the ratio of serum total to HDL cholesterol and in LDLand HDL-cholesterol concentrations when carbohydrates constituting 1% of energy are replaced isoenergetically with saturated, cis-monounsaturated, cis-polyunsaturated, or transmonounsaturated fatty acids. Source: Mensink et al. (2003).
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replaced with lauric, myristic and palmitic acid, LDL-cholesterol concentrations increased by 0.052 mmol/L (0.026, 0.078, P < 0.001), 0.048 mmol/L (0.027, 0.069, P < 0.001) and 0.039 mmol/L (0.027, 0.051, P < 0.001), respectively. Such evidence would suggest that only stearic acid, which decreased LDL-cholesterol concentrations by 0.0004 mmol/L (0.019, 0.011, P ¼ 0.464), was not detrimental to health. However, importantly, Mensink et al. (2003) also demonstrated that lauric, myristic, palmitic and stearic acids resulted in differential increases in HDL-cholesterol concentrations of 0.027 mmol/L (0.021, 0.033, P < 0.001), 0.018 mmol/L (0.013, 0.023, P ¼ 0.841), 0.010 mmol/L (0.007, 0.013, P ¼ 0.418) and 0.002 mmol/L (0.001, 0.006, P ¼ 0.390), respectively. As a result, overall, when compared with intake of carbohydrates, lauric acid decreased the ratio of total to HDL cholesterol, myristic and palmitic acid had little effect on the ratio, and stearic acid reduced the ratio slightly. The meta-analysis by Mensink et al. (2003) was the first large study to provide well-powered evidence that SFAs resulted in an increase in the total-to-HDL ratio after a 1% replacement of energy from carbohydrates, with a differential effect of SFAs depending on chain length. Moreover, Mensink et al. (2003) also demonstrated that replacement with cis-MUFA and cis-PUFA significantly reduced this ratio.
14.3.3.3 Dietary recommendations Dietary reference intakes published by the US Institute of Medicine (IoM) provided a comprehensive review of intakes, including dietary fats (IoM, 2005). The association between increasing SFA intake and increasing LDL cholesterol is listed as a welldocumented relationship. Specifically, the changes in serum LDL cholesterol expected from a 1% increase in energy from SFAs were summarised from three studies: 0.033 mmol/L (Mensink and Katan, 1992), 0.036 mmol/L (Clarke et al., 1997) and 0.045 mmol/L (Hegsted et al., 1993). The IoM recommended that SFA intake be as low as possible. In order to reduce intake of SFAs and follow a ‘healthful diet’, this report suggested choosing lean cuts of meat, trimming away visible fat on meats and eating smaller portions. Furthermore, the contribution of SFAs from butter could be minimised or replaced through the use of vegetable oils. In 2006, the American Heart Association (AHA) published diet and lifestyle recommendations (Lichtenstein et al., 2006). One of these goals recommended for the maintenance of health in the US population included ‘aiming for a desirable lipid profile’. The AHA highlighted that SFAs and trans-FAs were ‘the strongest dietary determinants of elevated LDL cholesterol’, and thus recommended intakes of SFAs of <7% of energy. In line with this guideline, the AHA highlights the fact that reducing SFA intake typically entails replacement of animal fats with unsaturated fats and lower-fat versions of foods. Within this report, the recommendations for FA intakes are supported by a study that investigated the effects of trans-FAs on cholesterol concentrations (Lichtenstein et al., 1999). Lichtenstein et al. (1999) conducted a double-blind Latin square-design study to test the effect of five sources of trans-FA (ranging from <0.5 to 20.1 g/100 g of fat) on serum LDL, HDL and total cholesterol. When compared with butter (1.5 g/100 g of fat), there was a clear dose–response relationship between an
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Total:HDL cholesterol
0.3 0.2 0.1 0 −0.1 −0.2 −0.3
—
−0.4 −0.5
Soya bean oil
Semi-liquid margarine
Soft margarine
Shortening
Stick margarine
Figure 14.3 Changes in serum total to HDL cholesterol after the consumption of diets enriched in soya bean oil; semi-liquid margarine; soft margarine; shortening; and stick margarine. Source: Lichtenstein et al. (1999).
increasing amount of trans-FA and a lower serum total cholesterol: HDL-cholesterol ratio (see Figure 14.3). In addition to the IoM and the AHA, the 2003 report by the World Health Organization (WHO) was referenced by EFSA as a supporting document for the positive relationship between SFA intake and cholesterol concentrations. Within this report, WHO recommended that intakes of SFAs should be limited to less than 10% of an individual’s daily energy intake. The basis for these recommendations was from studies demonstrating that SFAs raised total and LDL cholesterol (Grundy and Vega, 1988; Mensink and Katan, 1992; Katan et al., 1995), and that substituting SFAs with cis-MUFAs and n-6 PUFAs lowered these markers (Kris-Etherton, 1999). WHO cites studies that support the notion that SFAs raise total and LDL cholesterol and, to some extent, HDL cholesterol. Arguably, the strongest evidence referenced is the meta-analysis by Mensink and Katan (1992), where results from 27 controlled trials were compiled to generate equations that associated changes in FA intake to changes in serum HDL, LDL and total cholesterol. As demonstrated in Figure 14.4, replacement of 1% energy from carbohydrates with SFAs significantly increased HDL, LDL and total cholesterol and lowered triglycerides, whereas cis-MUFAs significantly increased HDL cholesterol and lowered triglycerides, and cis-PUFAs significantly increased HDL and LDL cholesterol and lowered total cholesterol and triglycerides. As a result, WHO concluded that under isoenergetic conditions, the most favourable strategy to lower coronary heart disease risk would be if SFAs were replaced with unsaturated FAs, with no decrease in total fat intake.
14.3.3.4 General discussion According to the UK recommendations by the National Institute for Health and Clinical Excellence (NICE), optimal total, LDL- and HDL-cholesterol concentrations are less than 5 and 2 mmol/L and greater than 1 mmol/L, respectively (NICE, 2008). Recent reports suggest that these targets are not being met (Townsend et al., 2012),
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Figure 14.4 Predicted changes of serum lipids and lipoproteins when 1% of energy as carbohydrates is replaced by fatty acids of a particular class under isocaloric, metanolic-ward or similar conditions. Source: Mensink and Katan (1992).
and thus strategies to encourage maintenance of healthy cholesterol concentrations, such as the implementation of health claims, are important. The substantiating evidence for the health claim relating to low or reduced SFAs and the maintenance of normal blood LDL-cholesterol concentrations vary considerably in their nature; some of the evidence is based on scientific reports written by EFSA, some are government reports on dietary recommendations and some are clinical trials (Table 14.1). Significantly, the aforementioned reports are classified as secondary references, given the evidence base for their recommendations are clinical trials. As a result, there are a relatively small number of studies that are referenced throughout these reports. In general, these studies are meta-analyses, which have
Summary of the main supporting evidence for the given EFSA claim
Table 14.1
References
Type
Main outcomes
Supporting references
EFSA (2004)
Scientific opinion
Mensink et al. (2003) and Judd et al. (2002)
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) (2010)
Scientific opinion
Consumption of transFA, like SFA, increases LDL-C, compared with consumption of cisMUFA and/or PUFA 1. SFA and trans-FA intake should be as low as possible 2. No daily reference value (DRV) for cisMUFA
Howell et al. (1997), Mensink et al. (2003) and Mozaffarian et al. (2006)
Continued
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Table 14.1
Foods, Nutrients and Food Ingredients with Authorised EU Health Claims
Continued
References
Type
Mensink et al. (2003)
Metaanalysis of clinical trials
IoM (2005)
Dietary advice
Lichtenstein et al. (2006)
Dietary advice
WHO/FAO (2003)
Dietary advice
Main outcomes 3. No DRV for the intake of total cis-PUFA 4. No specific values for the n-3/n-6 ratio 1. A 1% replacement of energy from carbohydrates with transMUFA increases the total:LDL-C ratio, while with SFA this marginally increases and with cisMUFA and cis-PUFA it significantly reduces 2. Not all SFAs have the same cholesterol-raising effect; those with a carbon chain length between 12 and 16 increase LDL-C to a greater extent Dietary reference intakes: 1. Limit SFA and transFA intake to as low as possible 2. Consume between 20% and 35% E from n-6 PUFA and 5–10% E from n-3 PUFA 1. ‘Aim for a desirable lipid profile’: <100 mg/dL LDL cholesterol 2. ‘Limit intake of SFA, trans-FA and cholesterol’: <7%E from SFA, typically by replacing with MUFA and/or PUFA 1. There is convincing evidence that the SFAs myristic and palmitic acid increase risk of CVD via their effects on LDL-C
Supporting references
60 randomised trials
Lichtenstein et al. (1999)
Kris-Etherton (1999) and Mensink and Katan (1992)
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amalgamated results from a large number of carefully selected randomised-controlled trials in order to generate an overall estimate of risk. Based on the totality of the evidence, there is a general consensus among the literature that increasing amounts of mixtures of SFAs in the diet will increase serum LDL-cholesterol concentrations. One potential mechanism behind this physiological response is a reduction in LDL-receptor-mediated clearance, possibly by inhibition of gene expression (Mustad et al., 1997). Although the health claim in question only mentions the relationship between SFAs and cholesterol, it is fundamental to consider the whole diet when estimating disease risk. As indicated in the literature, changes in cholesterol concentrations vary according to what SFAs are replaced with; trans-FAs and carbohydrates are detrimental in comparison to cis-MUFAs and cis-PUFAs. The unsaturated FAs, cis-MUFAs and cis-PUFAs are preferential to SFAs, trans-FAs and carbohydrates due to their ability to increase LDL-receptor-mediated clearance, increase reverse cholesterol transport (where cholesterol is transported from the peripheral tissue back to the liver for clearance) and act on important regulatory moieties (Fernandez and West, 2005). Furthermore, although the evidence is strong, the studies that are referenced are now more than a decade old in some instances. A recent review of studies that focused on cis-MUFAs and CVD concluded that evidence is still inconsistent and further work is needed (Schwingshackl and Hoffmann, 2012). Indeed, recent guidelines, such as the European guidelines on CVD prevention (Perk et al., 2012), still reference the meta-analysis by Mensink et al. (2003).
14.4
Other relevant legislation
In addition to the legislation surrounding the necessity to meet nutrition claim conditions for ‘LOW SATURATED FAT’ or ‘REDUCED’, other legislation may be relevant to the health claim in question. Specifically, the implementation of nutrient profiles in the future – pursuant to Article 4 of Regulation (EC) No. 1924/2006 (EU, 2006) – is likely to introduce a restriction on the use of health claims on products containing SFAs in excess of these profiles. Although the exact nature of this restriction is not yet known, it is possible that such products would not be permitted to bear a health claim. There are a number of parallels that can be drawn between the health claim in question and a health claim specifying that the replacement of SFAs with MUFAs and/or PUFAs is beneficial to cholesterol concentrations: ‘Replacement of mixtures of SFAs as present in foods or diets with mixtures of monounsaturated fatty acids (MUFAs) and/ or mixtures of polyunsaturated fatty acids (PUFAs), and maintenance of normal blood LDL-cholesterol concentrations’ (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2011). Given that the health claim in question relates to lower or reduced saturated fat intake, which when considered in terms of a whole diet indicates an increase in intake of another macronutrient, both claims are based on the same scientific substantiation. Despite sharing the same scientific basis, the conditions of the claims are different. Specifically, while the present claim must satisfy the ‘LOW SATURATED FAT’ and ‘REDUCED’ nutrition claims, as per the Annex of the Regulation (EC) No. 1924/2006 (EU, 2006), the other claim (Livingstone, 2014) may be used only
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for foods that are high in unsaturated fatty acids, as stipulated by the ‘HIGH UNSATURATED FAT’ claim. This nutrition claim states that ‘a claim that a food is high in unsaturated fat, and any claim likely to have the same meaning for the consumer may only be made where at least 70% of the FAs present in the product derive from unsaturated fat under the condition that unsaturated fat provides more than 20% of energy of the product’. As a result, there are subtle differences in the implications for product development between the two health claims.
14.5
Consumer issues
There are a number of consumer-related issues that should be brought to light when evaluating a health claim. First, the consumer understanding of the health claim should be considered, and second, the benefits of the health claim to the consumer should be objectively evaluated.
14.5.1 Consumer understanding of the health claim As specified by EU Regulation 1924/2006 Recital 15, all claims must be understood by the ‘average consumer’ – the average consumer being someone ‘who is reasonably well informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors’. Research suggests that well-educated individuals are more likely to understand the association between diet and disease (Cotunga et al., 1992), whereas less educated consumers are more prone to inappropriate interpretations of health messages. According to a study conducted by the USA Food and Drug Administration, the presence of a front-of-pack health claim can induce phenomena such as the ‘halo effect’ (where the product is rated higher on additional attributes that are not mentioned in the claim) and also the ‘magic bullet’ (where inappropriate health benefits are associated with the product) (Roe et al., 1999). Two reviews in this area came to the same conclusion with regard to consumer understanding of health claims – that, in general, they were difficult to understand (Williams, 2005; Wills et al., 2012). Wills et al. (2012) concluded that the degree of understanding varied according to the nature of the claim, knowledge about the claim or the substance in the claim, familiarity with the product and the claim and terminology used, and the respondent’s country of origin. Therefore, not only is there considerable effort needed for manufacturers to satisfy the conditions of the health claim, but also the claim itself needs to be understood by the consumer, which in some cases may require further information/education so as to avoid inappropriate consumer interpretations.
14.5.2 What are the benefits to consumers? The health claim in question specifies that the product contains low or reduced amounts of SFA, which is beneficial to the maintenance of normal blood LDLcholesterol concentrations. As a direct result, the main benefit to consumers would
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be the lower intake of SFA from that product. As highlighted in Section 14.3, the relationships between low SFA and LDL cholesterol, and low LDL cholesterol and lower risk of cardiovascular disease, have been supported by the totality of the scientific evidence. Nonetheless, these benefits are becoming increasingly contextualised, with an emphasis put on the diet as a whole, and particularly what SFAs are being replaced with in the product, as well as the overall diet. Retail trends suggest that having an added benefit to the consumer above that of the health claim are important drivers of sales. Such examples include the product being organic or fair trade. Furthermore, taking the example of fortified breakfast biscuits, the added convenience of having the product packaged for the on-the-go consumer is an added benefit to the consumer beyond that of the health claim.
14.6
Potential impact of the claim on product development
Reformulation is not necessary for a product to bear this claim if it already complies with the conditions of the ‘LOW SATURATED FAT’ or ‘REDUCED’ nutrition claims; that is, the sum of SFAs and trans-FAs in the product does not exceed 1.5 g/100 g for solids (or 0.75 g/100 ml for liquids), and the sum of SFAs and trans-FAs does not provide more than 10% of energy, or the reduction in content of SFA is at least 30% compared to a similar product. However, if a manufacturer were to reformulate its product in order to bear this claim, there would potentially be significant product development required so as to avoid undesirable changes in the structure and texture of the product that results from reducing the SFA content. Notable examples include concerns for foods that are hard and carry certain regulations (such as chocolate and Cheddar cheese), and also those where aeration and texture are key for the acceptability of the product. Taking the example of Cheddar cheese, the term Cheddar is protected in the United Kingdom under the Agricultural Produce (Grading and Marking) (Cheddar Cheese) Regulations of 1935 (French, 1935), but not at the EU level. In the United Kingdom, Cheddar cheese must be made from full-cream cow’s milk and have a minimum of 45% of butterfat in the moisture-free substance. Subsequently, this has a significant impact on product development, as low-fat alternatives can no longer be called Cheddar cheese. Furthermore, an example of where the fat content is fundamental for the product integrity is ice cream, as reviewed in Tabot (2011). Two means of reducing the SFA content are recommended: fractionation of milk fat to retain the low SFA fraction olein, and alteration of the dairy cow’s diet to increase the proportions of unsaturated FA in the milk. Alternatively, milk fat can be diluted through addition of liquid oil, although it is important to note that due to the lower melting point of unsaturated FAs, the meltdown profile of the subsequent products may be faster. A blend of an unsaturated oil and a saturated oil appears to be an optimum solution. Over the past decade, there has been considerable progress in the food industry in reducing the SFA content of foods (Table 14.2). Examples include United Biscuits,
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Summary of the pledges made by the 13 companies involved in the UK Department of Health-led ‘Responsibility Deal Saturated Fat Reduction Pledge 2013’
Table 14.2
Company
Pledge
Nestle´
Remove 3800 tonnes of saturated fat from more than a billion Kit Kat bars per year by reformulating the recipe Remove 32 tonnes of saturated fat from products such as breadsticks Reformulate its spreads’ range to reduce saturated fat; this will remove approximately 50 tonnes Increase the amount of 1% fat milk it supplies across its sites and increase the training it gives to its chefs Help one retailer remove 1.5 tonnes of saturated fat by switching to its half-fat cheese Reduce the amount of saturated fat in its Kids Pak™ by more than 70%; replace cookies and crisps with a healthier option that provides one of a child’s recommended five-a-day portions of fruit and vegetables Swap to lower fat ingredients and promote healthier menus Start a programme of saturated fat reformulation; explore reducing portion sizes and educating consumers and employees to choose healthier options Continue to reformulate recipes to reduce saturated fat Reformulate some of its top-selling cakes Continue to invest in spreads and blends that provide healthier options; in addition, it will promote healthy eating by encouraging swaps in cooking and baking with lower saturated fat alternatives Reformulate products across its portfolio, including BelVita, Oreo and Barny
Tesco Morrisons Aramark Cricketer Farm Subway
Compass Aldi
Sainsbury’s CH & Co Unilever
Mondelez International
Source: Department of Health (2013) press release. Available at https://www.gov.uk/government/news (accessed 21.04.14).
where the SFA content of Hula Hoops and Skips has been reduced by 80% since 2005; Nik Naks, Wheat Crunchies and Discos as well as McVitie’s Digestives, McVitie’s Hob Nobs and McVitie’s Rich Tea reduced by 50%; and McCoy’s reduced by 79% (Food and Drink Federation, 2012). Following more than 9 years of product development, and costing in excess of 6 million pounds, United Biscuits was given the gold award in the 2012 Community Partnership Awards for its contribution to public health. Further examples include McCain, where in 2008 SFAs were reduced by more than 70%; Nestle, with the development of ‘Skinny Cappaciono’ products with 66% less SFA than the standard products; and PepsiCo, where a £20 million investment saw up to an 80% reduction in SFA in the Walkers range. A large proportion of these changes were achieved through substitution of a high SFA fat type with higholeic sunflower oil, which contains only 9 g/100 g SFA and has a two to three times higher oxidative stability than other oils of comparable SFA content (Tabot, 2011).
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In October 2013, the UK Department of Health launched the Responsibility Deal Saturated Fat Reduction Pledge (Department of Health, 2013), which aims to remove thousands of tonnes of saturated fat from the UK nation’s diet. With 13 companies involved, representing almost half of the food manufacturing and retail industry, this pledge will have significant implications for public health. Table 14.2 summarises the pledges made by the companies involved. Processed foods such as ready meals, cheeses and snacks are thus arguably the most common sources of reformulation involving SFA content. Efforts have been made in the area of meats and processed meats and sauces in order to lower SFA content, although issues such as flavour changes have been concerns for product reformulation. For products that rely on SFA for their texture and baking quality, such as pastries and cakes, this strategy is a much greater technical challenge.
14.7
Future trends
With the growing trends in obesity and chronic diseases, and the mounting pressure to improve modifiable risk factors such as diet, the push to reduce unhealthy dietary components such as SFAs is likely to become even stronger. Reduction in total fat in order to reduce SFAs is the most cost-effective strategy, with fat replacers sometimes being used in order to maintain product characteristics. Nonetheless, there is a growing consensus in both the scientific and health professionals’ community that food constituents such as FAs are not a representative basis for recommendations, given that we consume whole foods and not nutrients. As such, future trends may focus on whole foods and dietary patterns, as outlined in the EFSA scientific opinion on establishing food-based dietary guidelines (EFSA, 2010). Nonetheless, nutrients should still be a prominent focus for the food industry and advisory bodies such as EFSA, who ultimately dictate the nutritional composition of our foods. The EFSA panel reviewed the health relationships relating to the cardiovascular system, heart and arteries, yet based the health claim in question on substantiating evidence linked to LDL-cholesterol concentrations. Due to the transitory nature of blood cholesterol, the use of this marker in predicting CVD is more limited than some of the more novel, holistic markers of CVD such as arterial stiffness (Vlachopoulos et al., 2010). Current research linking SFAs, cis-MUFAs and cis-PUFAs and arterial stiffness is limited (Livingstone et al., 2013); however, with the addition of future studies, there is potential to submit further claims to EFSA in relation to these markers. As previously highlighted, a future consideration will be the implication of nutrient profiles. There is likely to be a restriction on the use of health claims on products containing SFA in excess of these profiles, although the exact nature of this restriction is not yet known.
14.8
Conclusions
The evidence in support of the relationship between a low SFA intake and maintenance of normal blood LDL-cholesterol concentration is strong. However, what the consumer or manufacturer replaces SFA with is an important consideration that is
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not reflected in the given claim. With regard to consumer understanding, there is growing consensus that dietary recommendations are more effective when targeted at the food or meal level, as opposed to the nutrient level. Nonetheless, because the low and reduced SFA nutrition claims are widely used, the given health claim could be easily applied to a number of products.
14.9
Sources of further information and advice
There are a number of sources of further information regarding SFAs in foods and EU health claim legislation.
14.9.1 Saturated fat in foods A recent publication by Tabot, 2011 entitled Reducing saturated fats in foods provides an informative overview of SFAs, including sources and health aspects, and an indepth strategic evaluation of how to reduce the SFA content of various foods (milk and dairy products, butchered and processed meat products, savoury snacks and fried foods, biscuits, pastries, chocolate, ice cream and sauces).
14.9.2 EFSA The EFSA Website, http://www.efsa.europa.eu/, publishes useful information pertinent to European health, including current news and events. Opinions from the scientific committee/panel on health claims from Article 13, 13.5, 14 and 19 are also published online. For further information on the requirements for submission of a claim to EFSA, see the following report: Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1).
References AFSSA (Agence Franc¸aise de Se´curite´ Sanitaire des Aliments), 2001. Apports nutritionnels conseille´s pour la population franc¸aise. Editions Tec&Doc, Paris, 605 pp. Clarke, R., Frost, C., Collins, R., Appleby, P., Peto, R., 1997. Dietary lipids and blood cholesterol: quantitative meta-analysis of metabolic ward studies. Br. Med. J. (Clin. Res. Ed.) 314, 112–117. http://dx.doi.org/10.1136/bmj.314.7074.112. Cotunga, N., Subar, A.F., Heimendinger, J., Kahle, L., 1992. Nutrition and cancer prevention knowledge, beliefs, attitudes, and practices: the 1987 National Health Interview Survey. J. Am. Diet. Assoc. 92, 963–968. DACH, 2008. Referenzwerte f€ur die Na¨hrstoffzufuhr. Umschau Braus Verlag. Deutsche Gesell€ schaft f€ur Erna¨hrung – Osterreichische Gesellschaft f€ ur Erna¨hrung – Schweizerische Gesellschaft f€ur Erna¨hrungsforschung – Schweizerische Vereinigung f€ ur Erna¨hrung Frankfurt am Main. Department of Health, 1991. Dietary reference values for food energy and nutrients for the United Kingdom. Report of the Panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy, Her Majesty’s Stationery Office, London.
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Department of Health, 2013. Thousands of Tonnes of Saturated Fat to be Taken Out of the Nation’s Diet [Online]. Available: https://www.gov.uk/government/news/thousands-oftonnes-of-saturated-fat-to-be-taken-out-of-the-nations-diet (accessed 21.04.14.). EFSA, 2004. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the presence of trans fatty acids in foods and the effect on human health of the consumption of trans fatty acids. EFSA J. 81, 1–49. EFSA, 2010. Scientific Opinion on establishing Food-Based Dietary Guidelines. EFSA J. 8, 1460, Available: http://www.efsa.europa.eu/en/efsajournal/pub/1460.htm (accessed 10.05.14.). EFSA, 2011. Scientific Opinion on the substrantiation of health claims related to foods with reduced amounts of saturated fatty acids (SFAs) and maintenance of normal blood LDL-cholesterol concentrations (ID 620, 671, 4332) pursuant to Article 13(1) of Regulation (EC) No. 1924/2006. EFSA J. 9, 2062. EFSA, 2012. “General Function” Health Claims Under Article 13 of the European Food Safety Authority. Available: http://www.efsa.europa.eu/en/topics/topic/article13.htm (accessed 12.11.12.). EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2010. Scientific Opinion on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans fatty acids, and cholesterol. EFSA J. 8 (3), 1461 (107 pp.). http://dx.doi.org/10.2903/j.efsa.2010.1461; Available online: www.efsa. europa.eu/efsajournal. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2011. Scientific Opinion on the substantiation of health claims related to the replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with mixtures of monounsaturated fatty acids (MUFAs) and/or mixtures of polyunsaturated fatty acids (PUFAs), and maintenance of normal blood LDL cholesterol concentrations (ID 621, 1190, 1203, 2906, 2910, 3065) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA J. 9 (4), 2069 (18 pp.). http://dx. doi.org/10.2903/j.efsa.2011.2069; Available online: www.efsa.europa.eu/efsajournal. EU, 2006. Regulation (EC) No. 1924/2006 of the European Parliment and of the council of 20 December 2006 on nutrition and health claims made on foods by the European Food Safety Authority. Off. J. Eur. Union 404, 9–25. Fernandez, M.L., West, K.L., 2005. Mechanisms by which dietary fatty acids modulate plasma lipids. J. Nutr. 135, 2075–2078. Food and Drink Federation, 2012. Reformulation – Case Studies [Online]. Available: http:// www.fdf.org.uk/industry_casestudies/reformulation.aspx (accessed 24.11.12.). French, H.L., 1935. Agricultural Produce (Grading and Marking) (Cheddar Cheese) Regulations 1935, No. 1168, No. 1168. pp. 409–410. Gardner, C.D., Kraemer, H.C., 1995. Monounsaturated versus polyunsaturated dietary fat and serum lipids. A meta-analysis. Arterioscler. Thromb. Vasc. Biol. 15, 1917–1927. http://dx. doi.org/10.1161/01.ATV.15.11.1917. Givens, D.I., 2008. Session 4: challenges facing the food industry in innovating for health Impact on CVD risk of modifying milk fat to decrease intake of SFA and increase intake of cisMUFA. Proc. Nutr. Soc. 67, 419–427. http://dx.doi.org/10.1017/S0029665108008707. GR, 2001. Dietary Reference Intakes: Energy, Proteins, Fats and Digestible Carbohydrates by the Gezondheidsraad. Health Council of the Netherlands, The Hague, Publication no. 2001/19R. Grundy, S.M., Vega, G.L., 1988. Plasma cholesterol responsiveness to saturated fatty acids. Am. J. Clin. Nutr. 47, 822–824.
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Hegsted, D., Ausman, L., Johnson, J., Dallal, G., 1993. Dietary fat and serum lipids: an evaluation of the experimental data. Am. J. Clin. Nutr. 57, 875–883. HHS/USDA, 2005. Dietary Guidelines for Americans. US Department of Health and Human Services/US Department of Agriculture. Available: http://www.health.gov/ dietaryguidelines/dga2005/document/default.htm (accessed 12.01.12.). Howell, W.H., McNamara, D.J., Tosca, M., Smith, B., Gaines, J., 1997. Plasma lipid and lipoprotein responses to dietary fat and cholesterol: a meta-analysis. Am. J. Clin. Nutr. 65, 1747–1764. IOM, 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Institute of Medicine, The National Academies Press, Washington, DC. Judd, J.T., Baer, D.J., Clevidence, B.A., Kris-Etherton, P.M., Muesing, R.A., Iwane, M., 2002. Dietary cis and trans monounsaturated and saturated FA and plasma lipids and lipoproteins in men. Lipids 37, 123–131. Katan, M., Zock, P., Mensink, R., 1995. Dietary oils, serum lipoproteins, and coronary heart disease. Am. J. Clin. Nutr. 61 (6 Suppl.), 1368S–1373S. Kris-Etherton, P.M., 1999. Monounsaturated fatty acids and risk of cardiovascular disease. Circulation 100, 1253–1258. http://dx.doi.org/10.1161/01.CIR.100.11.1253. Kris-Etherton, P.M., Yu, S., 1997. Individual fatty acid effects on plasma lipids and lipoproteins: human studies. Am. J. Clin. Nutr. 65, 1628S–1644S. Lichtenstein, A.H., Ausman, L.M., Jalbert, S.M., Schaefer, E.J., 1999. Effects of different forms of dietary hydrogenated fats on serum lipoprotein cholesterol levels [published correction appears in N Engl J Med. 1999;34:856]. N. Engl. J. Med. 340, 1933–1940. http://dx.doi. org/10.1056/NEJM199906243402501. Lichtenstein, A.H., Appel, L.J., Brands, M., Carnethon, M., Daniels, S., Franch, H.A., Franklin, B., Kris-Etherton, P., Harris, W.S., Howard, B., Karanja, N., Lefevre, M., Rudel, L., Sacks, F., Van Horn, L., Winston, M., Wylie-Rosett, J., 2006. Diet and lifestyle recommendations revision 2006. Circulation 114, 82–96. http://dx.doi.org/10.1161/ circulationaha.106.176158. Livingstone, K.M., 2014. Fatty acid replacement. In: Sadler, M. (Ed.), Foods, Nutrients and Food Ingredients with Authorised EU Health Claims, vol. 1. Woodhead Publishing Ltd., Cambridge, pp. 298–317. Livingstone, K.M., Givens, D.I., Cockcroft, J.R., Pickering, J.E., Lovegrove, J.A., 2013. Is fatty acid intake a predictor of arterial stiffness and blood pressure in men? Evidence from the Caerphilly Prospective Study. Nutr. Metab. Cardiovasc. Dis. 23, 1079–1085. http://dx.doi. org/10.1016/j.numecd.2012.12.002. Mensink, R., Katan, M., 1992. Effect of dietary fatty acids on serum lipids and lipoproteins. A meta-analysis of 27 trials. Arterioscler. Thromb. Vasc. Biol. 12, 911–919. Mensink, R.P., Zock, P.L., Kester, A.D.M., Katan, M.B., 2003. Effects of dietary fatty acids and carbohydrates on the ratio of serum total to HDL cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am. J. Clin. Nutr. 77, 1146–1155. http://dx.doi.org/10.1161/01.ATV.12.8.911. Mozaffarian, D., Katan, M.B., Ascherio, A., Stampfer, M.J., Willett, W.C., 2006. Trans fatty acids and cardiovascular disease. N. Engl. J. Med. 354, 1601–1613. http://dx.doi.org/ 10.1056/NEJMra054035. Mustad, V.A., Etherton, T.D., Cooper, A.D., Mastro, A.M., Pearson, T.A., Jonnalagadda, S.S., Kris-Etherton, P.M., 1997. Reducing saturated fat intake is associated with increased levels of LDL receptors on mononuclear cells in healthy men and women. J. Lipid Res. 38, 459–468.
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NICE, 2008 Lipid Modification. National Institute for Health and Clinical Excellence. Available: http://www.nice.org.uk/nicemedia/pdf/CG67NICEguideline.pdf (accessed 27.05.12.). Perk, J., De Backer, G., Gohlke, H., Graham, I., Reiner, Zˇ., Verschuren, M., Albus, C., Benlian, P., Boysen, G., Cifkova, R., Deaton, C., Ebrahim, S., Fisher, M., Germano, G., Hobbs, R., Hoes, A., Karadeniz, S., Mezzani, A., Prescott, E., Ryden, L., Scherer, M., Syva¨nne, M., Scholte Op Reimer, W.J.M., Vrints, C., Wood, D., Zamorano, J.L., Zannad, F., European Association for Cardiovascular Prevention & Rehabilitation (EACPR), ESC Committee for Practice Guidelines (CPG), Cooney, M.T., Bax, J., Baumgartner, H., Ceconi, C., Dean, V., Fagard, R., Funck-Brentano, C., Hasdai, D., Kirchhof, P., Knuuti, J., Kolh, P., McDonagh, T., Moulin, C., Popescu, B.A., Sechtem, U., Sirnes, P.A., Tendera, M., Torbicki, A., Vahanian, A., Windecker, S., Aboyans, V., Ezquerra, E.A., Baigent, C., 2012. European guidelines on cardiovascular disease prevention in clinical practice (version 2012): the fifth joint task force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts) developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur. Heart J. 33, 1635–1701. http://dx.doi.org/10.1093/eurheartj/ehs092. Roe, B., Levy, A.S., Derby, B.M., 1999. The impact of health claims on consumer search and product evaluation outcomes: results from FDA experimental data. J. Public Policy Mark. 18, 89–105. Schwingshackl, L., Hoffmann, G., 2012. Monounsaturated fatty acids and risk of cardiovascular disease: synopsis of the evidence available from systematic reviews and meta-analyses. Nutrients 4, 1989–2007. http://dx.doi.org/10.3390/nu4121989. Tabot, G., 2011. Reducing Saturated Fats in Foods. Woodhead Publishing Limited, Cambridge. Townsend, N., Wickramasinghe, K., Bhatnagar, P., Smolina, K., Nichols, M., Leal, J., LuengoFernandez, R., Rayner, M., 2012. Coronary Heart Disease Statistics, 2012 ed., British Heart Foundation, London. Available: http://www.bhf.org.uk/publications/view-publication.aspx? ps¼1002097 (accessed 20.03.13.). Vlachopoulos, C., Aznaouridis, K., Stefanadis, C., 2010. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J. Am. Coll. Cardiol. 55, 1318–1327. http://dx.doi.org/10.1016/j.jacc.2009.10.061. WHO, 2003. Report of a Joint WHO/FAO Expert Consultation, WHO Technical Report Series 916. Diet, nutrition and the prevention of chronic diseases. WHO, Geneva. Williams, P., 2005. Consumer understanding and use of health claims for foods. Nutr. Rev. 63, 256–264. http://dx.doi.org/10.1111/j.1753-4887.2005.tb00382.x. Wills, J.M., Storcksdieck genannt Bonsmann, S., Kolka, M., Grunert, K.G., 2012. European consumers and health claims: attitudes, understanding and purchasing behaviour. Proc. Nutr. Soc. 71, 229–236. http://dx.doi.org/10.1017/S0029665112000043.
14
K.M. Livingstone Newcastle University, Newcastle upon Tyne, UK
14.1
Introduction
This chapter will evaluate the European Union (EU) approved health claim related to foods with low or reduced amounts of saturated fatty acids (SFAs) and maintenance of normal blood LDL-cholesterol concentrations, that was reviewed by the European Food Safety Authority (EFSA) in 2011 (EFSA, 2011). The characterisation of the food constituent, the scientific substantiation for the health claim and the conditions of use will be defined and evaluated. The wider impact of this claim will be discussed in relation to consumer issues, product development and future trends.
14.2
Characterisation of the substance
The constituents subject to characterisation were mixtures of SFAs as present in foods. EFSA (2011) concluded that SFAs were sufficiently characterised and the definition is summarised here: ‘Saturated fatty acids are aliphatic monocarboxylic acids with (generally) an even number of carbon atoms (usually from 4 to 20) and no double bonds, that can be liberated by hydrolysis of triacylglycerols from fats and oils. The most prevailing SFAs in the diet are lauric acid (12:0), myristic acid (14:0), palmitic acid (16:0) and stearic acid (18:0)’ (EFSA, 2011). See Figure 14.1.
14.3
Authorised EU health claim: low or reduced SFAs
The EFSA Panel on Dietetic Products, Nutrition and Allergies evaluated the scientific substantiation for the health claim relating to foods with low or reduced amounts of SFAs and maintenance of normal blood LDL-cholesterol concentrations. As an integral step in this evaluation, the wording of the claim and the conditions of use were defined.
Foods, Nutrients and Food Ingredients with Authorised EU Health Claims. http://dx.doi.org/10.1016/B978-1-78242-382-9.00014-1 © 2015 Elsevier Ltd. All rights reserved.
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O OH
Figure 14.1 Structure of the saturated fatty acid stearic acid.
14.3.1 Claim wording The proposed wording as defined by EFSA was as follows: ‘Consumption of saturated fat increases blood cholesterol concentrations; consumption of foods with reduced amounts of saturated fat may help to maintain normal blood cholesterol concentrations’ (EFSA, 2011). As a result, further to the authorisation procedures, the approved wording for use as a health claim was specified: ‘Reducing consumption of saturated fat contributes to the maintenance of normal blood cholesterol levels’ (EU register of claims: http://ec.europa.eu/nuhclaims).
14.3.2 Conditions of use In order to bear the health claim in question, the panel specified that the product should contain low or reduced amounts of SFAs, as per the Annex of the Regulation (EC) No. 1924/2006 (EU, 2006), and be in accordance with the guidance on the implementation of Regulation (EC) No. 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods. The given claim relates to foods with a low or reduced content of SFAs. As such, the conditions of the nutrition claims ‘LOW SATURATED FAT’ and ‘REDUCED’ should be met in order to make this health claim (http://ec.europa.eu/nuhclaims). As per the Annex of the Regulation (EC) No. 1924/2006, to claim that a food is low in SFAs, the sum of SFAs and trans-FAs in the product should not exceed 1.5 g/100 g for solids (or 0.75 g/100 ml for liquids), and the sum of SFAs and trans-FAs must not provide more than 10% of energy. Alternatively, if the conditions for the nutrition claim of reduced SFAs are satisfied, then the reduction in content of SFAs must be at least 30% compared to a similar product (EU, 2006).
14.3.3 Summary of substantiating evidence The recent scientific opinion, published by the EFSA panel, evaluated the scientific substantiation for the health claim relating to foods with low or reduced amounts of SFAs and the maintenance of normal LDL cholesterol. This report highlighted that the totality of the evidence supported a positive relationship between consumption of mixtures of SFAs, as present in foods, and total and LDL cholesterol, relative to carbohydrates, cis-MUFAs and cis-PUFAs. Although EFSA acknowledged the evidence relating to the differential effect of individual SFAs, including lauric, myristic, palmitic, stearic and short- and medium-chain SFAs (4–10 carbon atoms) on cholesterol concentrations, the mixture of these SFAs, as found in the diet, was the primary focus of the report. The following section will summarise and evaluate the main sources of
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scientific evidence used to substantiate the claimed effect between SFAs and cholesterol concentrations. The full list of supporting references provided to EFSA is available on the EFSA Website (EFSA, 2012).
14.3.3.1 EFSA opinions EFSA has published a number of opinions relating to SFAs and health. In 2004, the EFSA panel published an opinion on the effects of trans-FAs on human health (EFSA, 2004). Within this report, the parallels between the effects of trans-FAs and SFAs on LDL-cholesterol concentrations were investigated. Significantly, the meta-analysis by Mensink et al. (2003), as reviewed in Section 14.3.3.2, was cited as a main source of evidence for a detrimental effect of trans-FA on LDL and HDL cholesterol. As reported by Mensink et al. (2003), when 1% of energy in the diet from carbohydrates was replaced isoenergetically by trans-FA, LDL cholesterol was raised by as much as 0.040 mmol/L. Similarly, when the evidence for individual SFAs was collated, palmitic (+0.039 mmol/L), lauric (+0.052 mmol/L) and myristic acid (+0.048 mmol/L) also increased LDL cholesterol. Based on an evaluation of the scientific literature and current country-specific recommendations, the EFSA panel published a scientific opinion on the dietary reference values for fat (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2010). This report provided a review of the physiological role of fat, current European-wide levels of intake and a summary of country-specific recommendations for fat intake. With regard to SFAs, recommendations were set as follows: 10% total energy by the German-Austrian-Swiss authority (DACH, 2008), the UK Committee on Medical Aspects of Food Policy (Department of Health, 1991), the Health Council of the Netherlands (GR, 2001) and the Dietary Guidelines for Americans (HHS/USDA, 2005); and 8% energy from SFAs by the Nutritional Recommendations for the French Population (AFSSA, 2001). As substantiating evidence for setting EFSA-based dietary reference values, the effect of SFAs on cholesterol was reviewed, with reference to a number of metaanalyses (Gardner and Kraemer, 1995; Clarke et al., 1997; Howell et al., 1997; KrisEtherton and Yu, 1997; Mensink et al., 2003; Mozaffarian et al., 2006). Although EFSA declared that there was ‘wide consensus’ that SFAs raised total, LDL and HDL cholesterol relative to carbohydrates, it should be noted that data from two of the metaanalyses, Mensink et al. (2003) and Mozaffarian et al. (2006), differed in their estimation of the effect of SFAs based on their choice of reference group. While the former compared the effect of replacing carbohydrates with SFAs, cis-MUFAs, cisPUFAs and trans-MUFAs, the latter quantified the effect of replacing SFAs, cisMUFAs and cis-PUFAs, with trans-FAs. Nonetheless, the formulae utilised by Mozaffarian et al. (2006) were based on the methods previously used by Mensink et al. (2003). As reviewed by Givens (2008), the formulae devised by Mensink et al. (2003) can be rearranged to yield similar predicted changes in cholesterol concentrations when SFAs are replaced with either cis-MUFAs, cis-PUFAs or trans-FAs, thereby showing comparability between meta-analyses. Both meta-analyses were in agreement with respect to the LDL-cholesterol raising effect of SFAs and trans-MUFAs, compared
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with cis-MUFAs and cis-PUFAs, with SFAs being less detrimental to cholesterol levels than trans-MUFAs due to their ability to increase HDL-cholesterol concentrations. Based on this evidence, EFSA recommended that intakes of SFAs be as low as possible.
14.3.3.2 Randomised controlled trials
0.05
0.03 0.02 0.01 0 −0.01 −0.02 −0.03 −0.04
—
—
Cholesterol (mmol/L)
Total: HDL cholesterol
In addition to EFSA opinions, the panel based a large proportion of its decision on the strength of evidence for the given claim on results from randomised controlled trials. Specifically, quantitative summaries in the scientific literature, in the form of metaanalyses, were also included. Mensink et al. (2003) combined data on consumption of classes of FAs and individual FAs, from 60 studies, including 1672 individuals, in order to calculate the changes in total, LDL and HDL cholesterol and the total-toHDL-cholesterol ratio. Studies were only included if food intake was thoroughly controlled, and if parallel, crossover, or Latin square designs were used. Studies were also only included if feeding periods were longer than 13 days, and if adults did not have disturbances of lipid metabolism or diabetes. Comparison of replacement of 1% energy from carbohydrates with SFAs, cis-MUFAs, trans-MUFAs and cis-PUFAs (excluding long-chain n-3 PUFAs) indicated that both HDL and LDL cholesterol significantly increased. Critically, HDL and LDL cholesterol significantly increased and decreased, respectively, after replacement of SFAs with cis-MUFAs and cis-PUFAs. Furthermore, HDL and LDL cholesterol significantly decreased and increased, respectively, with trans-MUFA intake. Subsequently, there was a non-significant increase in the totalto-HDL-cholesterol ratio with SFAs, a significant increase in this ratio when replaced with trans-MUFAs and a decrease when replaced with cis-MUFAs and cis-PUFAs (see Figure 14.2). In addition to mixtures of SFAs, Mensink et al. (2003) also investigated the effects of individual FAs – lauric, myristic, palmitic and stearic acids – on cholesterol concentrations. Results confirmed that when 1% energy from carbohydrates was isoenergetically
Saturated Mono unsaturated Poly unsaturated trans
0.04 0.03 0.02 0.01 0 −0.01 −0.02 −0.03 HDL Saturated
Mono unsaturated
LDL Poly unsaturated
trans
Figure 14.2 Predicted changes (△) in the ratio of serum total to HDL cholesterol and in LDLand HDL-cholesterol concentrations when carbohydrates constituting 1% of energy are replaced isoenergetically with saturated, cis-monounsaturated, cis-polyunsaturated, or transmonounsaturated fatty acids. Source: Mensink et al. (2003).
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replaced with lauric, myristic and palmitic acid, LDL-cholesterol concentrations increased by 0.052 mmol/L (0.026, 0.078, P < 0.001), 0.048 mmol/L (0.027, 0.069, P < 0.001) and 0.039 mmol/L (0.027, 0.051, P < 0.001), respectively. Such evidence would suggest that only stearic acid, which decreased LDL-cholesterol concentrations by 0.0004 mmol/L (0.019, 0.011, P ¼ 0.464), was not detrimental to health. However, importantly, Mensink et al. (2003) also demonstrated that lauric, myristic, palmitic and stearic acids resulted in differential increases in HDL-cholesterol concentrations of 0.027 mmol/L (0.021, 0.033, P < 0.001), 0.018 mmol/L (0.013, 0.023, P ¼ 0.841), 0.010 mmol/L (0.007, 0.013, P ¼ 0.418) and 0.002 mmol/L (0.001, 0.006, P ¼ 0.390), respectively. As a result, overall, when compared with intake of carbohydrates, lauric acid decreased the ratio of total to HDL cholesterol, myristic and palmitic acid had little effect on the ratio, and stearic acid reduced the ratio slightly. The meta-analysis by Mensink et al. (2003) was the first large study to provide well-powered evidence that SFAs resulted in an increase in the total-to-HDL ratio after a 1% replacement of energy from carbohydrates, with a differential effect of SFAs depending on chain length. Moreover, Mensink et al. (2003) also demonstrated that replacement with cis-MUFA and cis-PUFA significantly reduced this ratio.
14.3.3.3 Dietary recommendations Dietary reference intakes published by the US Institute of Medicine (IoM) provided a comprehensive review of intakes, including dietary fats (IoM, 2005). The association between increasing SFA intake and increasing LDL cholesterol is listed as a welldocumented relationship. Specifically, the changes in serum LDL cholesterol expected from a 1% increase in energy from SFAs were summarised from three studies: 0.033 mmol/L (Mensink and Katan, 1992), 0.036 mmol/L (Clarke et al., 1997) and 0.045 mmol/L (Hegsted et al., 1993). The IoM recommended that SFA intake be as low as possible. In order to reduce intake of SFAs and follow a ‘healthful diet’, this report suggested choosing lean cuts of meat, trimming away visible fat on meats and eating smaller portions. Furthermore, the contribution of SFAs from butter could be minimised or replaced through the use of vegetable oils. In 2006, the American Heart Association (AHA) published diet and lifestyle recommendations (Lichtenstein et al., 2006). One of these goals recommended for the maintenance of health in the US population included ‘aiming for a desirable lipid profile’. The AHA highlighted that SFAs and trans-FAs were ‘the strongest dietary determinants of elevated LDL cholesterol’, and thus recommended intakes of SFAs of <7% of energy. In line with this guideline, the AHA highlights the fact that reducing SFA intake typically entails replacement of animal fats with unsaturated fats and lower-fat versions of foods. Within this report, the recommendations for FA intakes are supported by a study that investigated the effects of trans-FAs on cholesterol concentrations (Lichtenstein et al., 1999). Lichtenstein et al. (1999) conducted a double-blind Latin square-design study to test the effect of five sources of trans-FA (ranging from <0.5 to 20.1 g/100 g of fat) on serum LDL, HDL and total cholesterol. When compared with butter (1.5 g/100 g of fat), there was a clear dose–response relationship between an
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Total:HDL cholesterol
0.3 0.2 0.1 0 −0.1 −0.2 −0.3
—
−0.4 −0.5
Soya bean oil
Semi-liquid margarine
Soft margarine
Shortening
Stick margarine
Figure 14.3 Changes in serum total to HDL cholesterol after the consumption of diets enriched in soya bean oil; semi-liquid margarine; soft margarine; shortening; and stick margarine. Source: Lichtenstein et al. (1999).
increasing amount of trans-FA and a lower serum total cholesterol: HDL-cholesterol ratio (see Figure 14.3). In addition to the IoM and the AHA, the 2003 report by the World Health Organization (WHO) was referenced by EFSA as a supporting document for the positive relationship between SFA intake and cholesterol concentrations. Within this report, WHO recommended that intakes of SFAs should be limited to less than 10% of an individual’s daily energy intake. The basis for these recommendations was from studies demonstrating that SFAs raised total and LDL cholesterol (Grundy and Vega, 1988; Mensink and Katan, 1992; Katan et al., 1995), and that substituting SFAs with cis-MUFAs and n-6 PUFAs lowered these markers (Kris-Etherton, 1999). WHO cites studies that support the notion that SFAs raise total and LDL cholesterol and, to some extent, HDL cholesterol. Arguably, the strongest evidence referenced is the meta-analysis by Mensink and Katan (1992), where results from 27 controlled trials were compiled to generate equations that associated changes in FA intake to changes in serum HDL, LDL and total cholesterol. As demonstrated in Figure 14.4, replacement of 1% energy from carbohydrates with SFAs significantly increased HDL, LDL and total cholesterol and lowered triglycerides, whereas cis-MUFAs significantly increased HDL cholesterol and lowered triglycerides, and cis-PUFAs significantly increased HDL and LDL cholesterol and lowered total cholesterol and triglycerides. As a result, WHO concluded that under isoenergetic conditions, the most favourable strategy to lower coronary heart disease risk would be if SFAs were replaced with unsaturated FAs, with no decrease in total fat intake.
14.3.3.4 General discussion According to the UK recommendations by the National Institute for Health and Clinical Excellence (NICE), optimal total, LDL- and HDL-cholesterol concentrations are less than 5 and 2 mmol/L and greater than 1 mmol/L, respectively (NICE, 2008). Recent reports suggest that these targets are not being met (Townsend et al., 2012),
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Figure 14.4 Predicted changes of serum lipids and lipoproteins when 1% of energy as carbohydrates is replaced by fatty acids of a particular class under isocaloric, metanolic-ward or similar conditions. Source: Mensink and Katan (1992).
and thus strategies to encourage maintenance of healthy cholesterol concentrations, such as the implementation of health claims, are important. The substantiating evidence for the health claim relating to low or reduced SFAs and the maintenance of normal blood LDL-cholesterol concentrations vary considerably in their nature; some of the evidence is based on scientific reports written by EFSA, some are government reports on dietary recommendations and some are clinical trials (Table 14.1). Significantly, the aforementioned reports are classified as secondary references, given the evidence base for their recommendations are clinical trials. As a result, there are a relatively small number of studies that are referenced throughout these reports. In general, these studies are meta-analyses, which have
Summary of the main supporting evidence for the given EFSA claim
Table 14.1
References
Type
Main outcomes
Supporting references
EFSA (2004)
Scientific opinion
Mensink et al. (2003) and Judd et al. (2002)
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) (2010)
Scientific opinion
Consumption of transFA, like SFA, increases LDL-C, compared with consumption of cisMUFA and/or PUFA 1. SFA and trans-FA intake should be as low as possible 2. No daily reference value (DRV) for cisMUFA
Howell et al. (1997), Mensink et al. (2003) and Mozaffarian et al. (2006)
Continued
264
Table 14.1
Foods, Nutrients and Food Ingredients with Authorised EU Health Claims
Continued
References
Type
Mensink et al. (2003)
Metaanalysis of clinical trials
IoM (2005)
Dietary advice
Lichtenstein et al. (2006)
Dietary advice
WHO/FAO (2003)
Dietary advice
Main outcomes 3. No DRV for the intake of total cis-PUFA 4. No specific values for the n-3/n-6 ratio 1. A 1% replacement of energy from carbohydrates with transMUFA increases the total:LDL-C ratio, while with SFA this marginally increases and with cisMUFA and cis-PUFA it significantly reduces 2. Not all SFAs have the same cholesterol-raising effect; those with a carbon chain length between 12 and 16 increase LDL-C to a greater extent Dietary reference intakes: 1. Limit SFA and transFA intake to as low as possible 2. Consume between 20% and 35% E from n-6 PUFA and 5–10% E from n-3 PUFA 1. ‘Aim for a desirable lipid profile’: <100 mg/dL LDL cholesterol 2. ‘Limit intake of SFA, trans-FA and cholesterol’: <7%E from SFA, typically by replacing with MUFA and/or PUFA 1. There is convincing evidence that the SFAs myristic and palmitic acid increase risk of CVD via their effects on LDL-C
Supporting references
60 randomised trials
Lichtenstein et al. (1999)
Kris-Etherton (1999) and Mensink and Katan (1992)
Authorised EU health claims for low SFA foods
265
amalgamated results from a large number of carefully selected randomised-controlled trials in order to generate an overall estimate of risk. Based on the totality of the evidence, there is a general consensus among the literature that increasing amounts of mixtures of SFAs in the diet will increase serum LDL-cholesterol concentrations. One potential mechanism behind this physiological response is a reduction in LDL-receptor-mediated clearance, possibly by inhibition of gene expression (Mustad et al., 1997). Although the health claim in question only mentions the relationship between SFAs and cholesterol, it is fundamental to consider the whole diet when estimating disease risk. As indicated in the literature, changes in cholesterol concentrations vary according to what SFAs are replaced with; trans-FAs and carbohydrates are detrimental in comparison to cis-MUFAs and cis-PUFAs. The unsaturated FAs, cis-MUFAs and cis-PUFAs are preferential to SFAs, trans-FAs and carbohydrates due to their ability to increase LDL-receptor-mediated clearance, increase reverse cholesterol transport (where cholesterol is transported from the peripheral tissue back to the liver for clearance) and act on important regulatory moieties (Fernandez and West, 2005). Furthermore, although the evidence is strong, the studies that are referenced are now more than a decade old in some instances. A recent review of studies that focused on cis-MUFAs and CVD concluded that evidence is still inconsistent and further work is needed (Schwingshackl and Hoffmann, 2012). Indeed, recent guidelines, such as the European guidelines on CVD prevention (Perk et al., 2012), still reference the meta-analysis by Mensink et al. (2003).
14.4
Other relevant legislation
In addition to the legislation surrounding the necessity to meet nutrition claim conditions for ‘LOW SATURATED FAT’ or ‘REDUCED’, other legislation may be relevant to the health claim in question. Specifically, the implementation of nutrient profiles in the future – pursuant to Article 4 of Regulation (EC) No. 1924/2006 (EU, 2006) – is likely to introduce a restriction on the use of health claims on products containing SFAs in excess of these profiles. Although the exact nature of this restriction is not yet known, it is possible that such products would not be permitted to bear a health claim. There are a number of parallels that can be drawn between the health claim in question and a health claim specifying that the replacement of SFAs with MUFAs and/or PUFAs is beneficial to cholesterol concentrations: ‘Replacement of mixtures of SFAs as present in foods or diets with mixtures of monounsaturated fatty acids (MUFAs) and/ or mixtures of polyunsaturated fatty acids (PUFAs), and maintenance of normal blood LDL-cholesterol concentrations’ (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2011). Given that the health claim in question relates to lower or reduced saturated fat intake, which when considered in terms of a whole diet indicates an increase in intake of another macronutrient, both claims are based on the same scientific substantiation. Despite sharing the same scientific basis, the conditions of the claims are different. Specifically, while the present claim must satisfy the ‘LOW SATURATED FAT’ and ‘REDUCED’ nutrition claims, as per the Annex of the Regulation (EC) No. 1924/2006 (EU, 2006), the other claim (Livingstone, 2014) may be used only
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for foods that are high in unsaturated fatty acids, as stipulated by the ‘HIGH UNSATURATED FAT’ claim. This nutrition claim states that ‘a claim that a food is high in unsaturated fat, and any claim likely to have the same meaning for the consumer may only be made where at least 70% of the FAs present in the product derive from unsaturated fat under the condition that unsaturated fat provides more than 20% of energy of the product’. As a result, there are subtle differences in the implications for product development between the two health claims.
14.5
Consumer issues
There are a number of consumer-related issues that should be brought to light when evaluating a health claim. First, the consumer understanding of the health claim should be considered, and second, the benefits of the health claim to the consumer should be objectively evaluated.
14.5.1 Consumer understanding of the health claim As specified by EU Regulation 1924/2006 Recital 15, all claims must be understood by the ‘average consumer’ – the average consumer being someone ‘who is reasonably well informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors’. Research suggests that well-educated individuals are more likely to understand the association between diet and disease (Cotunga et al., 1992), whereas less educated consumers are more prone to inappropriate interpretations of health messages. According to a study conducted by the USA Food and Drug Administration, the presence of a front-of-pack health claim can induce phenomena such as the ‘halo effect’ (where the product is rated higher on additional attributes that are not mentioned in the claim) and also the ‘magic bullet’ (where inappropriate health benefits are associated with the product) (Roe et al., 1999). Two reviews in this area came to the same conclusion with regard to consumer understanding of health claims – that, in general, they were difficult to understand (Williams, 2005; Wills et al., 2012). Wills et al. (2012) concluded that the degree of understanding varied according to the nature of the claim, knowledge about the claim or the substance in the claim, familiarity with the product and the claim and terminology used, and the respondent’s country of origin. Therefore, not only is there considerable effort needed for manufacturers to satisfy the conditions of the health claim, but also the claim itself needs to be understood by the consumer, which in some cases may require further information/education so as to avoid inappropriate consumer interpretations.
14.5.2 What are the benefits to consumers? The health claim in question specifies that the product contains low or reduced amounts of SFA, which is beneficial to the maintenance of normal blood LDLcholesterol concentrations. As a direct result, the main benefit to consumers would
Authorised EU health claims for low SFA foods
267
be the lower intake of SFA from that product. As highlighted in Section 14.3, the relationships between low SFA and LDL cholesterol, and low LDL cholesterol and lower risk of cardiovascular disease, have been supported by the totality of the scientific evidence. Nonetheless, these benefits are becoming increasingly contextualised, with an emphasis put on the diet as a whole, and particularly what SFAs are being replaced with in the product, as well as the overall diet. Retail trends suggest that having an added benefit to the consumer above that of the health claim are important drivers of sales. Such examples include the product being organic or fair trade. Furthermore, taking the example of fortified breakfast biscuits, the added convenience of having the product packaged for the on-the-go consumer is an added benefit to the consumer beyond that of the health claim.
14.6
Potential impact of the claim on product development
Reformulation is not necessary for a product to bear this claim if it already complies with the conditions of the ‘LOW SATURATED FAT’ or ‘REDUCED’ nutrition claims; that is, the sum of SFAs and trans-FAs in the product does not exceed 1.5 g/100 g for solids (or 0.75 g/100 ml for liquids), and the sum of SFAs and trans-FAs does not provide more than 10% of energy, or the reduction in content of SFA is at least 30% compared to a similar product. However, if a manufacturer were to reformulate its product in order to bear this claim, there would potentially be significant product development required so as to avoid undesirable changes in the structure and texture of the product that results from reducing the SFA content. Notable examples include concerns for foods that are hard and carry certain regulations (such as chocolate and Cheddar cheese), and also those where aeration and texture are key for the acceptability of the product. Taking the example of Cheddar cheese, the term Cheddar is protected in the United Kingdom under the Agricultural Produce (Grading and Marking) (Cheddar Cheese) Regulations of 1935 (French, 1935), but not at the EU level. In the United Kingdom, Cheddar cheese must be made from full-cream cow’s milk and have a minimum of 45% of butterfat in the moisture-free substance. Subsequently, this has a significant impact on product development, as low-fat alternatives can no longer be called Cheddar cheese. Furthermore, an example of where the fat content is fundamental for the product integrity is ice cream, as reviewed in Tabot (2011). Two means of reducing the SFA content are recommended: fractionation of milk fat to retain the low SFA fraction olein, and alteration of the dairy cow’s diet to increase the proportions of unsaturated FA in the milk. Alternatively, milk fat can be diluted through addition of liquid oil, although it is important to note that due to the lower melting point of unsaturated FAs, the meltdown profile of the subsequent products may be faster. A blend of an unsaturated oil and a saturated oil appears to be an optimum solution. Over the past decade, there has been considerable progress in the food industry in reducing the SFA content of foods (Table 14.2). Examples include United Biscuits,
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Foods, Nutrients and Food Ingredients with Authorised EU Health Claims
Summary of the pledges made by the 13 companies involved in the UK Department of Health-led ‘Responsibility Deal Saturated Fat Reduction Pledge 2013’
Table 14.2
Company
Pledge
Nestle´
Remove 3800 tonnes of saturated fat from more than a billion Kit Kat bars per year by reformulating the recipe Remove 32 tonnes of saturated fat from products such as breadsticks Reformulate its spreads’ range to reduce saturated fat; this will remove approximately 50 tonnes Increase the amount of 1% fat milk it supplies across its sites and increase the training it gives to its chefs Help one retailer remove 1.5 tonnes of saturated fat by switching to its half-fat cheese Reduce the amount of saturated fat in its Kids Pak™ by more than 70%; replace cookies and crisps with a healthier option that provides one of a child’s recommended five-a-day portions of fruit and vegetables Swap to lower fat ingredients and promote healthier menus Start a programme of saturated fat reformulation; explore reducing portion sizes and educating consumers and employees to choose healthier options Continue to reformulate recipes to reduce saturated fat Reformulate some of its top-selling cakes Continue to invest in spreads and blends that provide healthier options; in addition, it will promote healthy eating by encouraging swaps in cooking and baking with lower saturated fat alternatives Reformulate products across its portfolio, including BelVita, Oreo and Barny
Tesco Morrisons Aramark Cricketer Farm Subway
Compass Aldi
Sainsbury’s CH & Co Unilever
Mondelez International
Source: Department of Health (2013) press release. Available at https://www.gov.uk/government/news (accessed 21.04.14).
where the SFA content of Hula Hoops and Skips has been reduced by 80% since 2005; Nik Naks, Wheat Crunchies and Discos as well as McVitie’s Digestives, McVitie’s Hob Nobs and McVitie’s Rich Tea reduced by 50%; and McCoy’s reduced by 79% (Food and Drink Federation, 2012). Following more than 9 years of product development, and costing in excess of 6 million pounds, United Biscuits was given the gold award in the 2012 Community Partnership Awards for its contribution to public health. Further examples include McCain, where in 2008 SFAs were reduced by more than 70%; Nestle, with the development of ‘Skinny Cappaciono’ products with 66% less SFA than the standard products; and PepsiCo, where a £20 million investment saw up to an 80% reduction in SFA in the Walkers range. A large proportion of these changes were achieved through substitution of a high SFA fat type with higholeic sunflower oil, which contains only 9 g/100 g SFA and has a two to three times higher oxidative stability than other oils of comparable SFA content (Tabot, 2011).
Authorised EU health claims for low SFA foods
269
In October 2013, the UK Department of Health launched the Responsibility Deal Saturated Fat Reduction Pledge (Department of Health, 2013), which aims to remove thousands of tonnes of saturated fat from the UK nation’s diet. With 13 companies involved, representing almost half of the food manufacturing and retail industry, this pledge will have significant implications for public health. Table 14.2 summarises the pledges made by the companies involved. Processed foods such as ready meals, cheeses and snacks are thus arguably the most common sources of reformulation involving SFA content. Efforts have been made in the area of meats and processed meats and sauces in order to lower SFA content, although issues such as flavour changes have been concerns for product reformulation. For products that rely on SFA for their texture and baking quality, such as pastries and cakes, this strategy is a much greater technical challenge.
14.7
Future trends
With the growing trends in obesity and chronic diseases, and the mounting pressure to improve modifiable risk factors such as diet, the push to reduce unhealthy dietary components such as SFAs is likely to become even stronger. Reduction in total fat in order to reduce SFAs is the most cost-effective strategy, with fat replacers sometimes being used in order to maintain product characteristics. Nonetheless, there is a growing consensus in both the scientific and health professionals’ community that food constituents such as FAs are not a representative basis for recommendations, given that we consume whole foods and not nutrients. As such, future trends may focus on whole foods and dietary patterns, as outlined in the EFSA scientific opinion on establishing food-based dietary guidelines (EFSA, 2010). Nonetheless, nutrients should still be a prominent focus for the food industry and advisory bodies such as EFSA, who ultimately dictate the nutritional composition of our foods. The EFSA panel reviewed the health relationships relating to the cardiovascular system, heart and arteries, yet based the health claim in question on substantiating evidence linked to LDL-cholesterol concentrations. Due to the transitory nature of blood cholesterol, the use of this marker in predicting CVD is more limited than some of the more novel, holistic markers of CVD such as arterial stiffness (Vlachopoulos et al., 2010). Current research linking SFAs, cis-MUFAs and cis-PUFAs and arterial stiffness is limited (Livingstone et al., 2013); however, with the addition of future studies, there is potential to submit further claims to EFSA in relation to these markers. As previously highlighted, a future consideration will be the implication of nutrient profiles. There is likely to be a restriction on the use of health claims on products containing SFA in excess of these profiles, although the exact nature of this restriction is not yet known.
14.8
Conclusions
The evidence in support of the relationship between a low SFA intake and maintenance of normal blood LDL-cholesterol concentration is strong. However, what the consumer or manufacturer replaces SFA with is an important consideration that is
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Foods, Nutrients and Food Ingredients with Authorised EU Health Claims
not reflected in the given claim. With regard to consumer understanding, there is growing consensus that dietary recommendations are more effective when targeted at the food or meal level, as opposed to the nutrient level. Nonetheless, because the low and reduced SFA nutrition claims are widely used, the given health claim could be easily applied to a number of products.
14.9
Sources of further information and advice
There are a number of sources of further information regarding SFAs in foods and EU health claim legislation.
14.9.1 Saturated fat in foods A recent publication by Tabot, 2011 entitled Reducing saturated fats in foods provides an informative overview of SFAs, including sources and health aspects, and an indepth strategic evaluation of how to reduce the SFA content of various foods (milk and dairy products, butchered and processed meat products, savoury snacks and fried foods, biscuits, pastries, chocolate, ice cream and sauces).
14.9.2 EFSA The EFSA Website, http://www.efsa.europa.eu/, publishes useful information pertinent to European health, including current news and events. Opinions from the scientific committee/panel on health claims from Article 13, 13.5, 14 and 19 are also published online. For further information on the requirements for submission of a claim to EFSA, see the following report: Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1).
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NICE, 2008 Lipid Modification. National Institute for Health and Clinical Excellence. Available: http://www.nice.org.uk/nicemedia/pdf/CG67NICEguideline.pdf (accessed 27.05.12.). Perk, J., De Backer, G., Gohlke, H., Graham, I., Reiner, Zˇ., Verschuren, M., Albus, C., Benlian, P., Boysen, G., Cifkova, R., Deaton, C., Ebrahim, S., Fisher, M., Germano, G., Hobbs, R., Hoes, A., Karadeniz, S., Mezzani, A., Prescott, E., Ryden, L., Scherer, M., Syva¨nne, M., Scholte Op Reimer, W.J.M., Vrints, C., Wood, D., Zamorano, J.L., Zannad, F., European Association for Cardiovascular Prevention & Rehabilitation (EACPR), ESC Committee for Practice Guidelines (CPG), Cooney, M.T., Bax, J., Baumgartner, H., Ceconi, C., Dean, V., Fagard, R., Funck-Brentano, C., Hasdai, D., Kirchhof, P., Knuuti, J., Kolh, P., McDonagh, T., Moulin, C., Popescu, B.A., Sechtem, U., Sirnes, P.A., Tendera, M., Torbicki, A., Vahanian, A., Windecker, S., Aboyans, V., Ezquerra, E.A., Baigent, C., 2012. European guidelines on cardiovascular disease prevention in clinical practice (version 2012): the fifth joint task force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts) developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur. Heart J. 33, 1635–1701. http://dx.doi.org/10.1093/eurheartj/ehs092. Roe, B., Levy, A.S., Derby, B.M., 1999. The impact of health claims on consumer search and product evaluation outcomes: results from FDA experimental data. J. Public Policy Mark. 18, 89–105. Schwingshackl, L., Hoffmann, G., 2012. Monounsaturated fatty acids and risk of cardiovascular disease: synopsis of the evidence available from systematic reviews and meta-analyses. Nutrients 4, 1989–2007. http://dx.doi.org/10.3390/nu4121989. Tabot, G., 2011. Reducing Saturated Fats in Foods. Woodhead Publishing Limited, Cambridge. Townsend, N., Wickramasinghe, K., Bhatnagar, P., Smolina, K., Nichols, M., Leal, J., LuengoFernandez, R., Rayner, M., 2012. Coronary Heart Disease Statistics, 2012 ed., British Heart Foundation, London. Available: http://www.bhf.org.uk/publications/view-publication.aspx? ps¼1002097 (accessed 20.03.13.). Vlachopoulos, C., Aznaouridis, K., Stefanadis, C., 2010. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J. Am. Coll. Cardiol. 55, 1318–1327. http://dx.doi.org/10.1016/j.jacc.2009.10.061. WHO, 2003. Report of a Joint WHO/FAO Expert Consultation, WHO Technical Report Series 916. Diet, nutrition and the prevention of chronic diseases. WHO, Geneva. Williams, P., 2005. Consumer understanding and use of health claims for foods. Nutr. Rev. 63, 256–264. http://dx.doi.org/10.1111/j.1753-4887.2005.tb00382.x. Wills, J.M., Storcksdieck genannt Bonsmann, S., Kolka, M., Grunert, K.G., 2012. European consumers and health claims: attitudes, understanding and purchasing behaviour. Proc. Nutr. Soc. 71, 229–236. http://dx.doi.org/10.1017/S0029665112000043.