30 Functional foods The micronutrients included all those listed in the directive on nutrition labelling(90/496/EEC) plus a number of other trace minerals such as selenium copper and manganese. The antioxidant vitamins C, E and beta-carotene were present at levels of daily intake above the recommended daily allowances (RDAS) used for nutrition labelling purposes in Europe. In addition the formulators of the product wanted to add other carotenoids such as lycopene and lutein as additional in vivo antioxidants The product was to be available in three flavours with the appropriate colours. The marketing objective in the country of origin was to market the product not only as a nutritious beverage but also to position it for convalescents, athletes and as a meal replacement for weight control purposes 2.3 Product positioning in the European market The definition of the product from the marketing point of view was found to be critical. some of the recommended uses fell into the definition of dietetic as given in the directive on foods for particular nutritional uses (89/398/EEC)2 known as the PaRnUtS directive. There is a specific directive in force, 96/8/EC, which controls both the composition and labelling of foods marketed as meal replacements for use in weight control diets. The composition of such meal replacements must comply with very detailed criteria with respect to the energy, protein, carbohydrate, fat and micronutrient content. The product as developed did not meet all the criteria so the decision had to be made to market it as a convenient healthy beverage applicable to a range of lifestyles 2.4 Product composition a detailed investigation had to be carried out on every component, whether ingredient or additive, to ensure compliance with the various European la 2.4.1 Protein The protein contribution was made up of both isolated soya protein and casein (milk protein). The specifications and origins of both had to be checked. To comply with the Council Regulation(EC) No. 1139/98 on the labelling of genetically modified soya or maize, the provenance of the soya had to be traced and certification obtained that it did not contain genetically modified protein There is a European Directive 83/417/EEC laying down the specification and quality criteria for caseinates and the ingredient had to be checked for compliance
The micronutrients included all those listed in the directive on nutrition labelling (90/496/EEC)1 plus a number of other trace minerals such as selenium, copper and manganese. The antioxidant vitamins C, E and beta-carotene were present at levels of daily intake above the recommended daily allowances (RDAs) used for nutrition labelling purposes in Europe. In addition the formulators of the product wanted to add other carotenoids such as lycopene and lutein as additional in vivo antioxidants. The product was to be available in three flavours with the appropriate colours. The marketing objective in the country of origin was to market the product not only as a nutritious beverage but also to position it for convalescents, athletes and as a meal replacement for weight control purposes. 2.3 Product positioning in the European market The definition of the product from the marketing point of view was found to be critical. Some of the recommended uses fell into the definition of dietetic as given in the directive on foods for particular nutritional uses (89/398/EEC)2 known as the PARNUTS directive. There is a specific directive in force, 96/8/EC,3 which controls both the composition and labelling of foods marketed as meal replacements for use in weight control diets. The composition of such meal replacements must comply with very detailed criteria with respect to the energy, protein, carbohydrate, fat and micronutrient content. The product as developed did not meet all the criteria so the decision had to be made to market it as a convenient healthy beverage applicable to a range of lifestyles. 2.4 Product composition A detailed investigation had to be carried out on every component, whether ingredient or additive, to ensure compliance with the various European laws. 2.4.1 Protein The protein contribution was made up of both isolated soya protein and casein (milk protein). The specifications and origins of both had to be checked. To comply with the Council Regulation (EC) No. 1139/98 on the labelling of genetically modified soya or maize,4 the provenance of the soya had to be traced and certification obtained that it did not contain genetically modified protein or DNA. There is a European Directive 83/417/EEC laying down the specification and quality criteria for caseinates and the ingredient had to be checked for compliance.5 30 Functional foods
EU legislation and functional foods 31 2.4.2Fat he fat contribution was supplied from an oil high in polyunsaturated fatty acids plus some lecithin. The specification and typical analyses of the oil were obtained to ensure that permitted maximum levels of erucic acid in the oil were not likely to be exceeded. Erucic acid is a normal constituent of seed oils which has been shown to have detrimental effects on health if consumed in large quantities. There is a limit for erucic acid from oils used in compounded foods where the overall fat content of the food exceeds 5%. The details are given in Directive 76/621/EEC, with the method of analysis in Directive 80/891/EEC Directive 76/621/EEC also gives a derogation for member states to apply the provisions of the directive to foods where the total fat content is equal to or less than 5% Due to the high polyunsaturated content of the oil it was more susceptible to oxidation(rancidity)than many oils used in such products. The presence of number of mineral salts in the product also increased the risk of rapid rancidity Permitted antioxidants for fats and oils are given in the directive on additives other than colours and sweeteners (95/2/EC). As the proposed source of the oil was North America, discussions had to be conducted with the suppliers to ensure that the oil was adequately protected using only the antioxidants and permitted levels given in the directive. As European law in this area differs significantly from that in the USA, this caused considerable problems which were only resolved by changing to a different grade of oil to that originally preferred Legal complications were also encountered with the lecithin. In early 1999 when the work was being carried out, Regulation(EC) No. 1139/98 on the labelling of genetically modified(GM) soya and maize was in force but the proposed exclusion list for highly processed soya and maize derivatives had not been adopted. The original source of lecithin proved positive when tested for DNA from GM soya. Alternative supplies were offered from South America but these were found to have differences in their functional characteristics from the original source. The legal requirement to label the lecithin containing the gm DNA was based on its primary function in the product. At that time, the regulation only covered food ingredients from GM soya and maize and specifically excluded additives and flavourings. Lecithins are approved additives and appear in Annex I to Directive 95/2/EC as being generally permitted in foodstuffs According to the formulator of the product, the lecithin had been included for wo reasons: the first was technological, to improve wetting-out characteristics when the powder was mixed into the liquid; and the second was nutritional, to provide a source of phospholipids. This situation, where substances can have dual roles in foods as additives and nutrients, is not uncommon in European food law. The decision was originally made in early 1999 that the primary function of lecithin in the product was as a technological additive and the marketing department had the option not to make the label statement on the gm source This option was negated in January 2000 when the European Regulation(EC) 50/2000 on the labelling of additives and flavourings from gm sources was
2.4.2 Fat The fat contribution was supplied from an oil high in polyunsaturated fatty acids plus some lecithin. The specification and typical analyses of the oil were obtained to ensure that permitted maximum levels of erucic acid in the oil were not likely to be exceeded. Erucic acid is a normal constituent of seed oils which has been shown to have detrimental effects on health if consumed in large quantities. There is a limit for erucic acid from oils used in compounded foods where the overall fat content of the food exceeds 5%. The details are given in Directive 76/621/EEC,6 with the method of analysis in Directive 80/891/EEC.7 Directive 76/621/EEC also gives a derogation for member states to apply the provisions of the directive to foods where the total fat content is equal to or less than 5%. Due to the high polyunsaturated content of the oil it was more susceptible to oxidation (rancidity) than many oils used in such products. The presence of a number of mineral salts in the product also increased the risk of rapid rancidity. Permitted antioxidants for fats and oils are given in the directive on additives other than colours and sweeteners (95/2/EC).8 As the proposed source of the oil was North America, discussions had to be conducted with the suppliers to ensure that the oil was adequately protected using only the antioxidants and permitted levels given in the directive. As European law in this area differs significantly from that in the USA, this caused considerable problems which were only resolved by changing to a different grade of oil to that originally preferred. Legal complications were also encountered with the lecithin. In early 1999, when the work was being carried out, Regulation (EC) No. 1139/98 on the labelling of genetically modified (GM) soya and maize was in force but the proposed exclusion list for highly processed soya and maize derivatives had not been adopted. The original source of lecithin proved positive when tested for DNA from GM soya. Alternative supplies were offered from South America but these were found to have differences in their functional characteristics from the original source. The legal requirement to label the lecithin containing the GM DNA was based on its primary function in the product. At that time, the regulation only covered food ingredients from GM soya and maize and specifically excluded additives and flavourings. Lecithins are approved additives and appear in Annex 1 to Directive 95/2/EC as being generally permitted in foodstuffs. According to the formulator of the product, the lecithin had been included for two reasons: the first was technological, to improve wetting-out characteristics when the powder was mixed into the liquid; and the second was nutritional, to provide a source of phospholipids. This situation, where substances can have dual roles in foods as additives and nutrients, is not uncommon in European food law. The decision was originally made in early 1999 that the primary function of lecithin in the product was as a technological additive and the marketing department had the option not to make the label statement on the GM source. This option was negated in January 2000 when the European Regulation (EC) 50/2000 on the labelling of additives and flavourings from GM sources was EU legislation and functional foods 31
32 Functional foods adopted.However, while the decision was made to specify the lecithin as an dditive. its contribution had to be added to the total fat content given in the nutrition information on the label. Directive 90/496/EEC on nutrition labelling specifically includes phospholipids in the definition of fat. 2.4.3 Carbohydrate The main carbohydrate component of the product consisted of a mixture of dextrose, fructose and maltodextrin. As these ingredients can be produced from maize, the gm status of each had to be determined. The product was also found to contain relatively small amounts of sorbitol, principally as a component of some compounded ingredients. Under European law the definition of carbohydrates for labelling purposes includes the polyols, of which sorbitol is one, but requires the energy calculation for the contribution from sorbitol to be made with a different factor. Carbohydrates(excluding polyols) must be calculated on the basis of kcal/g whereas polyols are at 2. 4kcal/g. Also, for the purposes of nutrition labelling, the statement of carbohydrate content had to be subdivided into sugars, polyols and starch. The legal definition of sugars includes all monosaccharides and disaccharides in the foods but excludes polyols 2.4.手 Fibre The added fibre and fructo-oligosaccharides presented a number of legal problems, particularly in the quantification of the fibre content. There is no formal definition of dietary fibre in European food law. When Directive 90/496/EEC was adopted, the definition of fibre was given as follows fibre means the material to be defined in accordance with the procedure laid down in Article 10(of Directive 90/496/EEC) and measured by the method of analysis to be determined in accordance with that procedure This statement resulted from a major disagreement in 1990 among the member states as to what constituted dietary fibre. Almost ten years later this had not been resolved. The debate has revolved around the specific components of non-digestible plant matter that collectively contribute to the dietary fibre content and should be included in the analysis. An early definition of dietary fibre was ' the plant polysaccharides and lignin which are resistant to hydrolysis by the digestive enzymes of man. There are more recent schools of thought that fibre should be defined more closely as 'non-starch polysaccharides (NSP) NSPs are the major fraction of fibre and are chemically identifi Britis authorities are in favour of the definition being NSP as measured by the Englyst method, while some other member states prefer to use a concept of fibre that includes other substances such as lignin. There are a number of ways of chemically determining the fibre content of foods depending on the definition used and the components included in the definition
adopted.9 However, while the decision was made to specify the lecithin as an additive, its contribution had to be added to the total fat content given in the nutrition information on the label. Directive 90/496/EEC on nutrition labelling specifically includes phospholipids in the definition of fat. 2.4.3 Carbohydrate The main carbohydrate component of the product consisted of a mixture of dextrose, fructose and maltodextrin. As these ingredients can be produced from maize, the GM status of each had to be determined. The product was also found to contain relatively small amounts of sorbitol, principally as a component of some compounded ingredients. Under European law the definition of carbohydrates for labelling purposes includes the polyols, of which sorbitol is one, but requires the energy calculation for the contribution from sorbitol to be made with a different factor. Carbohydrates (excluding polyols) must be calculated on the basis of 4kcal/g whereas polyols are at 2.4kcal/g. Also, for the purposes of nutrition labelling, the statement of carbohydrate content had to be subdivided into sugars, polyols and starch. The legal definition of sugars includes all monosaccharides and disaccharides in the foods, but excludes polyols. 2.4.4 Fibre The added fibre and fructo-oligosaccharides presented a number of legal problems, particularly in the quantification of the fibre content. There is no formal definition of dietary fibre in European food law. When Directive 90/496/EEC was adopted, the definition of fibre was given as follows: fibre means the material to be defined in accordance with the procedure laid down in Article 10 (of Directive 90/496/EEC) and measured by the method of analysis to be determined in accordance with that procedure. This statement resulted from a major disagreement in 1990 among the member states as to what constituted dietary fibre. Almost ten years later this had not been resolved. The debate has revolved around the specific components of non-digestible plant matter that collectively contribute to the dietary fibre content and should be included in the analysis. An early definition of dietary fibre was ‘the plant polysaccharides and lignin which are resistant to hydrolysis by the digestive enzymes of man’. There are more recent schools of thought that fibre should be defined more closely as ‘non-starch polysaccharides (NSP)’. NSPs are the major fraction of fibre and are chemically identifiable. The British authorities are in favour of the definition being NSP as measured by the Englyst method, while some other member states prefer to use a concept of fibre that includes other substances such as lignin. There are a number of ways of chemically determining the fibre content of foods depending on the definition used and the components included in the definition. 32 Functional foods
EU legislation and functional foods 33 The British authorities have consistently insisted that the quantitative declaration of fibre content given on the label should be based on NSP measured by the Englyst method. Since the adoption of the directive on nutrition labelling in 1990, they have been persistent in trying to persuade the other member states to agree to accept a definition based on NSP. This has not succeeded and in 1996 the British Ministry of Agriculture, Fisheries and Food issued a statement saying that although they still regarded the Englyst method or one giving the same results, as the official method in UK law, manufacturers could label with fibre content determined by other methods such as the AOAC provided the method of analysis was declared on the label. o However, it was also stated that claims for fibre could only be made on values determined by the Englyst method. This meant that in order to make a claim for a high fibre content for the product in the Uk, it had to contain at least 6g per 100g of NSP measured by the Englyst method. If the AOAC method, commonly accepted by other eu countries had been used the actual declaration of fibre content on the label would have been much greater, but no claim for it could be made on the pack or in advertising. In 1999 the British government issued proposals for the labelling of fibre to be based on the AOAC method. Unfortunately, as a result of long consultation period, these proposals had not been introduced into law by the time the product was launched A further complexity surrounding the fibre claim was that the product contained significant amounts of inulin and other fructo-oligosaccharides which have been shown to have a beneficial(prebiotic)effect on the gut microflora The status of these substances in terms of labelling have been the subject of considerable debate in Europe, particularly in the UK. In 1997 the British government Committee on the Medical Aspects of Food Policy(the COMA Committee) was asked to consider the inclusion of inulin and oligofructose in the uk definition of dietary fibre for labelling purposes. In a statement in April 1998 the committee reported that it had agreed to retain the existing definition based on NSPs, but to consider additional categories for declaring resistant starch and non-digestible oligosaccharides on product labels. A year later the committee was asked to reconsider its decision and reported again in April 1999 that, having reviewed submissions in support of the application, the committee was not convinced by the evidence presented and concluded that inulin and oligofructose should not be included in the definition. This decision meant that these substances could not be added to the fibre content for the uk label and had to be declared separately on the statement of nutritional information. These differences in the definition of fibre meant that there would have to be a dichotomy in the marketing strategy between the UK and the rest of Eure 2. 4.5 Micronutrients The proposed addition of a wide range of micronutrients caused considerable problems. The fortification of foods with vitamins and minerals is one aspect of European food law that is still under discussion and has not yet reached the stage
The British authorities have consistently insisted that the quantitative declaration of fibre content given on the label should be based on NSP measured by the Englyst method. Since the adoption of the directive on nutrition labelling in 1990, they have been persistent in trying to persuade the other member states to agree to accept a definition based on NSP. This has not succeeded and in 1996 the British Ministry of Agriculture, Fisheries and Food issued a statement saying that although they still regarded the Englyst method, or one giving the same results, as the official method in UK law, manufacturers could label with fibre content determined by other methods such as the AOAC, provided the method of analysis was declared on the label.10 However, it was also stated that claims for fibre could only be made on values determined by the Englyst method. This meant that in order to make a claim for a high fibre content for the product in the UK, it had to contain at least 6g per 100g of NSP measured by the Englyst method. If the AOAC method, commonly accepted by other EU countries, had been used, the actual declaration of fibre content on the label would have been much greater, but no claim for it could be made on the pack or in advertising. In 1999 the British government issued proposals for the labelling of fibre to be based on the AOAC method. Unfortunately, as a result of a long consultation period, these proposals had not been introduced into law by the time the product was launched. A further complexity surrounding the fibre claim was that the product contained significant amounts of inulin and other fructo-oligosaccharides which have been shown to have a beneficial (prebiotic) effect on the gut microflora. The status of these substances in terms of labelling have been the subject of considerable debate in Europe, particularly in the UK. In 1997 the British government Committee on the Medical Aspects of Food Policy (the COMA Committee) was asked to consider the inclusion of inulin and oligofructose in the UK definition of dietary fibre for labelling purposes. In a statement in April 1998 the committee reported that it had agreed to retain the existing definition based on NSPs, but to consider additional categories for declaring resistant starch and non-digestible oligosaccharides on product labels. A year later the committee was asked to reconsider its decision and reported again in April 1999 that, having reviewed submissions in support of the application, the committee was not convinced by the evidence presented and concluded that inulin and oligofructose should not be included in the definition.11 This decision meant that these substances could not be added to the fibre content for the UK label and had to be declared separately on the statement of nutritional information. These differences in the definition of fibre meant that there would have to be a dichotomy in the marketing strategy between the UK and the rest of Europe. 2.4.5 Micronutrients The proposed addition of a wide range of micronutrients caused considerable problems. The fortification of foods with vitamins and minerals is one aspect of European food law that is still under discussion and has not yet reached the stage EU legislation and functional foods 33
34 Functional foods of a draft directive. The complexities of legislating in this area were outlined in a European Commission discussion paper in 1997 Across Europe there has been no consistent approach to the addition of vitamins and minerals to foods. Some countries. such as the uk and the Netherlands, have relatively liberal policies while others, such as Spain and Ireland, impose very strict controls. Throughout the EU, there are 15 different sets of laws covering the addition of vitamins and minerals to foods and they all differ in detail from each other. Some of these differences are very significant. Many countries use the Rda as a basis for the legal control of vitamins minerals. For example, Germany permits vitamins, excluding vitamins A and D to be added to foods up to 3 x RDa per daily intake of the food The addition of vitamins A and D to foods is prohibited, with only some specific exceptions Belgium has complex legislation with vitamins A and D at 1 x RDA, the b vitamins. C and e at 3 x RDA and most others at 2 x RDA. and formal notification is required. Spain and Ireland both impose an upper limit of I X RDA on micronutrients in foods. In addition, French law does not permit the addition of micronutrients to foods but permits restoration of vitamins at levels between 80% and 200% and minerals at between 80% and 120% of the natural content of the food before processing, al though the addition of micronutrients to foods for particular nutritional uses(PARNUTS products) is allowed in France Some countries only permit micronutrient addition to foods on the basis of individual product authorisations. A further complication was that some of the countries only allowed the addition to foods of the 12 vitamins and 6 minerals that appear in the Annex to Directive 90/496/EEC. This list does not include the trace elements copper and selenium which appear in the specific PaRnUtS directives and are recognised as being essential in these foods e These complexities meant that the added micronutrient content of the product her had to be reduced to the lowest common denominator from each countrys requirements or a marketing decision had to be made to market the product initially in those countries where the legislation was most compatible with the original product concept. Eventually, the latter option was preferred as the fir substantially reduced both the number of micronutrients that could be added to the products and also their level of input Once the list of micronutrients had been determined the chemical forms in which they could be added also had to be checked. This was important as, for the minerals particularly, some of the salts and organic forms of the nutrients are not officially recognised in many countries in Europe. The only guideline that was available was the draft list and opinion of the European Commissions Scientific Committee on Food relating to approved nutrient sources for PARNUTS foods. This draft was published in May 1999, almost exactly ten years after the quirement for such a list was given in Article 4(2)of the PARNUTS Directive 89/398/EEC
of a draft directive. The complexities of legislating in this area were outlined in a European Commission discussion paper in 1997.12 Across Europe there has been no consistent approach to the addition of vitamins and minerals to foods. Some countries, such as the UK and the Netherlands, have relatively liberal policies while others, such as Spain and Ireland, impose very strict controls. Throughout the EU, there are 15 different sets of laws covering the addition of vitamins and minerals to foods and they all differ in detail from each other. Some of these differences are very significant. Many countries use the RDA as a basis for the legal control of vitamins or minerals. For example, Germany permits vitamins, excluding vitamins A and D, to be added to foods up to 3 RDA per daily intake of the food. The addition of vitamins A and D to foods is prohibited, with only some specific exceptions. Belgium has complex legislation with vitamins A and D at 1 RDA, the B vitamins, C and E at 3 RDA and most others at 2 RDA, and formal notification is required. Spain and Ireland both impose an upper limit of 1 RDA on micronutrients in foods. In addition, French law does not permit the addition of micronutrients to foods but permits restoration of vitamins at levels between 80% and 200% and minerals at between 80% and 120% of the natural content of the food before processing, although the addition of micronutrients to foods for particular nutritional uses (PARNUTS products) is allowed in France. Some countries only permit micronutrient addition to foods on the basis of individual product authorisations. A further complication was that some of the countries only allowed the addition to foods of the 12 vitamins and 6 minerals that appear in the Annex to Directive 90/496/EEC. This list does not include the trace elements copper, manganese and selenium which appear in the specific PARNUTS directives and are recognised as being essential in these foods. These complexities meant that the added micronutrient content of the product either had to be reduced to the lowest common denominator from each country’s requirements or a marketing decision had to be made to market the product initially in those countries where the legislation was most compatible with the original product concept. Eventually, the latter option was preferred as the first substantially reduced both the number of micronutrients that could be added to the products and also their level of input. Once the list of micronutrients had been determined, the chemical forms in which they could be added also had to be checked. This was important as, for the minerals particularly, some of the salts and organic forms of the nutrients are not officially recognised in many countries in Europe. The only guideline that was available was the draft list and opinion of the European Commission’s Scientific Committee on Food relating to approved nutrient sources for PARNUTS foods.13 This draft was published in May 1999, almost exactly ten years after the requirement for such a list was given in Article 4(2) of the PARNUTS Directive 89/398/EEC. 34 Functional foods