Commission Document, 17 January.2003
The following is the Explanatory Memorandum from this draft
1. In its White Paper on Food Safety, the Commission announced that it would put forward a proposal for harmonising rules on the addition of nutrients to food in the European Union (Action no. 61). It is widely recognised today that relevant national rules vary widely and very often result in obstacles to intra-community trade in such products. Therefore it is necessary to harmonise these rules in order to facilitate the free circulation of these products within the Community. At the same time harmonisation would ensure a high level of consumer protection across the Community in general and notably ensure that products concerned do not present any risk for public health.
2. Addition of nutrients is generally practised by manufactures either voluntarily or because it is compulsory under national or Community rules. Thus, addition of vitamins and/or minerals is compulsory for a number of foods for particular nutritional uses (dietetic foods) by Community law. At national level, in some Member States, the addition of vitamins and/or minerals is mandatory in margarine (Vitamins A and D), flour (B complex vitamins, iron, and calcium), and salt (iodine). These national rules are dictated by public health considerations that are relevant to national or regional level and the rationale for their mandatory nature cannot be applied at Community level. Therefore, this proposed Regulation does not affect the existing Community rules on addition of nutrients and is not intended to harmonise existing national rules on compulsory addition of nutrients to foods. This proposal aims to harmonise the rules on the voluntary addition of nutrients in the European Union.
3. The nutrients most commonly added to foods for the purposes mentioned above are vitamins and minerals. For this reason it is considered appropriate for this proposed Regulation to cover only the addition of vitamins and minerals to foods. Some other nutrients are specifically allowed by Community legislation to be added to foods for particular nutritional uses (dietetic foods). Thus amino acids may be added to foods such as infant formulae and follow-on formulae based on soya for improving the quality of the protein. Certain fatty acids also are added to such products for satisfying the particular nutritional requirements of the persons for whom they are intended. However, as said above, rules concerning such products are not the subject of this proposed Regulation.
4. Vitamins and minerals are added to food for three purposes. Firstly, for restoring in the final product offered to the consumer the amount of nutrient(s) lost during the various stages of the storage, handling and manufacturing of foods. Such losses are very often inevitable and may occur even when the latest state of the art in manufacturing process is applied. Secondly, for producing substitute foods that resembles common food in appearance, organoleptic properties and nutritive value. The most well-known of such products is margarine, which was originally produced as a substitute to butter. Thirdly, vitamins and minerals are added to foods for the purpose of fortifying or enriching foods with them, irrespective of whether or not the nutrients are originally present in the food.
5. As already mentioned, national rules on the voluntary addition of vitamins and minerals vary widely. This is the result of a differing appreciation of the various arguments that are being considered when regulating their addition to foods. Food has two basic functions. One is to provide pleasure and the other is to provide nutrition, that is all the necessary elements for growth, development and maintenance of a healthy life. In addition, food must be safe. Most would agree that in the context of the addition of vitamins and minerals for the purposes outlined above, products to which vitamins and minerals are added should offer to consumers a plausible beneficial nutritional or physiological effect and should be safe when consumed as part of a varied diet.
6. European Union citizens in general have at their disposal a variety of safe foods at affordable prices. Ideally, they should be able to choose a diet that provides all necessary nutrients in adequate quantities according to their individual needs. However, many studies have demonstrated that all individuals do not achieve this ideal situation across the European Union. This may be due to a variety of reasons. Changes to economic and social situations, such as increased proportion of working women and changes in family structures, affect food purchasing, meal preparation and the number and nature of meals eaten at home. The application of technological progress, both at work and at home, and changes to other life-style factors have contributed to changing dietary needs, in particular a reduction in energy requirements. For example, the UK National Food Survey of 1998 showed that in UK households there has been a 30% decline in the average energy intakes of adults, from 2700 calories in 1960 to 1800 calories in 1998. As a result substantial modifications of eating habits and dietary behaviour have occurred that would place substantial importance on the micronutrient density (amount of vitamins and minerals per given amount of energy) of individual foods and overall diets. In addition, scientific progress has led to a reappraisal of dietary needs for certain nutrients because their effect on specific conditions or diseases has been established or because the baseline that determines need is moving from preventing deficiencies towards ensuring optimal health.
7. It is widely recognised that different groups of the population may be affected. The report of the Scientific Co-operation (SCOOP) task on the scientific considerations for the development of measures on the addition of vitamins and minerals to foods states: "The results suggest that for almost all vitamins, minerals and trace elements there exist one or more population groups with intakes below nationally recommended levels. However, some nutrients are mentioned more often than others: iron, iodine and vitamins B2, B6 and D". The population groups may include adolescents or children, particularly "picky" ones, women, women during the periconceptual period, the elderly, people on a diet for losing weight, people on vegetarian diets, an increasing number of people having allergies to foods, persons eating a high proportion of "fast foods" or "junk foods" and others. The combinations of the specific groups of the population and the nutrients for which the intake may be deficient vary from one Member State of the Union to another. (Should examples be given?).
8. Foods to which vitamins and minerals have been added voluntarily can make a contribution, sometimes significant, to achieving adequate intakes of them and consequently reducing the risk of deficiencies. It is estimated that in general margarine and spreadable fats to which vitamin A and D are added, voluntarily in the great majority of the Member States, contribute about 20% of the Population Reference Intake (PRI) of vitamin A intake and about 30% of the PRI of vitamin D intake for very important groups of the EU population. Fortified breakfast cereals have become, in the 1990s, the principal source of iron in young children's diets in the UK, replacing meat that was the principle source in the 1950s. The same products can also contribute 20% of vitamin D intake and about 20% of intakes of B vitamins in the diets of children. (Fortified fruit juices contribute about of calcium and Vitamin C intakes of German adolescents?). Therefore, in general, the availability and consumption of these foods can make a significant contribution to nutrient intakes.
9. At international level General Principles for the addition of essential nutrients to foods were adopted by the Codex Alimentarius in 1987. These General Principles provide definitions for the three cases of addition of nutrients to foods mentioned above, namely restoration, nutritional equivalence of substitute foods and fortification or enrichment. The Codex definitions in the first two cases remain valid to a large extent today and could be therefore included in this proposed Directive. The definition of fortification merits more careful consideration in the context of European Union legislation on the subject.
10. The Codex General Principles, according to the definition of fortification, would allow addition of nutrients to foods "for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific groups of the population". This is a definition that was adopted fifteen years ago having in mind the nutritional situation worldwide at the time. It gives emphasis to preventing or correcting a demonstrated deficiency of a vitamin or a mineral, a situation that was likely to occur, particularly in developing countries. This definition would result in a very restrictive regime of fortification and would be difficult to retain for the European Union for a number of reasons. Nutrient deficiencies for specific vitamins and minerals demonstrated by agreed clinical symptoms or other biomarkers are very few, if any, in the European Union today. They would not concern the whole of the EU population but rather specific groups which would not necessarily exist or be the same in all the Member States. Therefore, acceptance of fortification only for such restricted purposes would eliminate the basis for harmonising the EU rules on voluntary addition of nutrients to foods and give reason to those advocating that rules for the addition of nutrients to foods, voluntary or mandatory, should remain the responsibility of national authorities.
11. On the other hand, intakes below the recommended intakes for various vitamins and minerals, as defined at national level, have been reported in many Member States for different groups of the population as mentioned above. Various physiological parameters indicate a poor nutritional status for them too. These indicators of "deficiencies" of vitamins and minerals should therefore be taken into account today. Further, it is very important to take note of the evolution of scientific thinking with regard to recommended intakes. In the very recent past these would aim to cover the needs of the vast majority of the population in order to avoid deficiencies. Today more recent recommendations from scientific bodies of Member States and of third countries are aimed at providing intakes that would contribute to "optimal health" for the population. These take into account evolving scientific knowledge on the role and the beneficial effects of certain vitamins and minerals on certain physiological processes and conditions. It is true that many of the beneficial relationships between vitamin and mineral intakes and health are put forward as plausible benefits based on scientific evidence rather than proof. But many would point out that proof may take yet some time. Thus although evidence about the relationship between folic acid and neural tube defects existed for some time, proof came only a few years ago. Selenium was shown to be essential in animals in 1958 whilst it was accepted as essential to humans in 1980 and similar stories can be told for zinc and chromium. There have been reports about boron, silicon, molybdenum, tin, vanadium and other trace elements having a function in animals but because there are no deficiencies or reduced biochemical activity demonstrated in humans the potential beneficial effects of their intake for man remain very much in doubt.
12. The above arguments, which would be in favour of a less strict approach on the addition of vitamins and minerals to foods, are often countered by arguments as to the potential risks that such an approach may entail. Such risks could be the result of two possible effects of fortification. First, it is feared that voluntary fortification practised by the manufacturers in a liberal environment would result in a substantial proliferation of fortified foods. These could progressively replace non-fortified foods in the diet and thus result in excessive intakes of certain nutrients that would represent a risk to the health of consumers. This is a legitimate concern. However, evidence from Member States and third countries, where voluntary fortification is allowed without many or any restrictions, show that the feared proliferation of fortified foods has been fairly limited. Today in these countries, according to data provided by the manufacturers, such foods represent 1-6% of the food supply, a percentage that has remained stable in recent years. In any case, there are measures to be adopted that would avoid risks of excess consumption of vitamins and minerals. Therefore, prohibiting or severely restricting fortification to avoid risk of excess consumption of vitamins and minerals would be considered a disproportionate measure to take at European Union level.
13. Another serious concern is that the proliferation of fortified foods may undermine consumer knowledge of basic nutritional principles and perception of foods. Some national authorities and consumer organisations claim that after substantial efforts they have succeeded in educating consumers about the nutritional value of the different foods and the importance of having a varied diet for ensuring the necessary intakes of the essential nutrients. Fortification could result in diminishing the current importance, in consumers' minds, of certain categories of foods such as fruits, vegetables, dairy products and red meat as sources of vitamins and minerals. People could turn to fortified foods for their vitamin and mineral intakes, change their dietary patterns and thus jeopardise good dietary habits. This, it is feared, could have a detrimental effect on the quantity, quality and ratio of intakes of certain nutrients and other substances, such as fibre, protein, fat and carbohydrate, and constitute a long-term risk for the population. This is also a legitimate concern which, however, at this stage is based on a hypothesis for future market evolution, supported by the observation that often the fortification of foods is used as a promotional tool by the manufacturers. It is not supported by any evidence for such adverse effects in any Community Member State or third countries having experience with voluntary addition of nutrients. Therefore, again, there are measures that can be taken which would be more proportionate than a prohibition or severe restriction of fortification.
14 Instead of severe restrictions to fortification across the board some would advocate selective restrictions to the foods or categories of foods that can be fortified. Practices in some third countries are cited as examples. Thus the USA Food and Drug Administration "does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry or fish products; sugars or snack foods such as candies and carbonated beverages". The Australia and New Zealand regulatory principles for voluntary addition of vitamins and minerals to general foods allow the addition "to some basic foods providing the vitamin or mineral is present in the nutrient profile, prior to processing, of a closely associated reference food in the food group to which the basic food belongs". However they allow the addition of some nutrients to certain categories of foods, even if the criteria are not met, where such additions are historically established (e.g. calcium and vitamin C added to breakfast cereals). They also set certain specific "nutritional quality" limits for allowing some categories of foods to be fortified (biscuits containing up to 200 g/kg fat and not more than 50g/kg sugar). Health Canada, in policy recommendations on the addition of vitamins and minerals to foods, put forward in 1999 criteria for selecting foods to which vitamins and minerals should be allowed to be added. Such foods would be those that provide 10% or more of the Canadian recommended nutrient intake for at least one nutrient and that would not contain "disqualifying" nutrient levels (proposed for total fats, saturates and trans fatty acids, and sodium). However it was recognised that "foods of low nutritional value and foods with high levels of those nutrients for which reduced intake is desirable could also be potential vehicles for reaching specific groups in certain circumstances (e.g. fruit-flavoured drinks and whole milk)". No rules have yet been adopted by Canada following the publication of the above policy document.
15. Some consumer organisations in the European Union consider that products that do not have a "desirable" nutritional profile, such as candies, high salt and high fat snacks or high fat and sugar biscuits and cakes should not be allowed to be fortified. Such foods, they consider, would become more attractive because of their fortification and they would be consumed in greater quantities by many consumers who are currently eating them in moderation. This, they consider, would have a more immediate negative effect in the dietary habits of certain particularly vulnerable sections of the population, like children and adolescents.
16. Such restrictions, although based on understandable concerns and important arguments, would be challenged by a number of scientific and policy arguments. The concept of prohibiting the addition of vitamins and minerals to certain foods on the basis of their "nutritional profile" is contrary to the basic principle in nutrition that there are not "good" and "bad" foods but rather "good" and "bad" diets. Such advice certainly recommends judicious food choices and moderation in consumption of certain products but accepts that, in a long-term varied diet, all foods could be included in appropriate frequency and quantities. The examples of recommendations, policy proposals and applicable rules mentioned in point 15 amply demonstrate that there is a lack of consistently defined and widely acceptable criteria for selecting the products or categories of products that should be allowed to be fortified or not. Permission to add vitamins and minerals only to foods that originally contain them is strongly contested because such a criterion would unnecessarily deprive certain groups of the population of valuable intakes of some nutrients. For example, consumption of fruit juices or fruit-flavoured soft drinks fortified with calcium may contribute to reaching desirable levels of calcium intakes by persons who cannot drink milk for physiological, taste or social reasons. Cultural and culinary traditions in the different Member States would further complicate the choice of different foods or groups of foods as appropriate or inappropriate for fortification. Total fat, saturates, trans fatty acids, sugars, sodium or salt, at variable levels, are commonly cited as criteria for the "nutritional profile" of products. More complicated schemes involving many more parameters may be under study. But all these proposals are currently far from meeting with the required consensus. The exception would be alcoholic beverages. Given the efforts made against alcohol abuse, addition of vitamins and minerals to these products should be prohibited as is proposed to prohibit any claims for them. It should also be clear that the above considerations apply to manufactured foods and that vitamins and minerals should not be added to fresh and non-transformed produce such as fruits, vegetables, meat, poultry, fish etc.
17. It is worth mentioning a few other points that would be relevant for the complete consideration of the issue. Consumers are becoming more and more conscious about the relationship between nutrition in general and intakes of certain nutrients in particular and health. Therefore, rightly or wrongly, they are increasingly seeking products to which vitamins and minerals have been added. As mentioned in the Nordic Council of Ministers report on the Addition of Nutrients to Foods, in a study conducted in the Nordic countries on behalf of a food company, 78% of consumers in those countries believed that consumers should have the possibility and choice to buy foods fortified with vitamins and minerals although not as many would choose the fortified version (only 33% would choose it). The above figures indicate that it is important for consumers to have choice between fortified and non-fortified foods. Therefore, all those concerned should ensure that allowing voluntary fortification should not lead to the disappearance of the non-fortified versions from the mass distribution chain. This will be a substantial responsibility of the food industry who, on the other hand, requests that the rules on the addition of vitamins and minerals to foods are not unduly restrictive. This would enable it to develop innovative products, beneficial for the consumers, and remain competitive not only at the Community and wider European level but also worldwide. This will be of particular importance now that the obligation has been established, through the recently adopted general principles and requirements of food law, that food exported from the Community for placing on the market of a third country shall comply with the relevant requirements of Community law.
18. In view of the above, it is considered that measures that would be more proportionate than a prohibition or severe restriction of fortification should be taken at Community level. The information for the consumer about the nutritional profile of the product could be improved through the labelling. Thus nutrition labelling should become mandatory for all foods to which vitamins and minerals are added. It should also be complete in order to give a better overall picture of the food. Specific statements relevant to the importance of a diversified diet can serve to remind and reinforce consumer knowledge on this specific point. As said above, the issue of claims made for fortified products is very important. Claims can give an improved image to fortified foods and hence their potential value as a promotional tool is considerable. Proposals for the harmonisation of claims for foods in general are being put forward by the Commission in parallel with the present proposal on the addition of vitamins and minerals to foods. Appropriate control of relevant claims would be another measure for controlling the impact of fortified foods on the choices of consumers. In parallel efforts to inform and educate consumers on nutritional issues and the importance of good dietary habits for better health and overall well-being should be maintained and, where possible, reinforced.
19. However, there should be vigilance regarding the evolution of the situation once the harmonised rules begin to apply in the European Union. In order to identify any adverse developments that may appear to occur and take the necessary action to prevent or minimise them Member State authorities should be able to monitor the marketing of products to which vitamins and minerals are added as best they can. For this reason they should be able, if they consider it necessary, to require those responsible for the marketing of these products to notify their marketing. Authorities, scientific bodies and interested stakeholders should co-operate as much as possible in order to best gather data concerning food intakes that are comparable across the European Union, identify intakes of foods to which vitamins and minerals have been added and estimate with the best possible accuracy the intake of these nutrients. In addition, the gathering of data on relevant indicators should be given priority at national and at European Union level. The Commission should proceed, after a reasonable period following the effective application of the adopted rules, to analyse and report on their effect on the issues mentioned above and any others that may become relevant and to propose any appropriate measures that may be deemed necessary.
20. As said before, it is necessary to adopt measures to ensure that there will be no risk from excessive consumption of nutrients from a varied diet that includes also foods to which vitamins and minerals have been added. It is well known that excessive intakes of some vitamins and minerals would present greater risks to public health than others. A classification to categories according to the potential risk has been proposed by the Nordic Nutrition Recommendations, the French Food Safety Authority and other scientific sources and they tend to coincide. The Scientific Committee for Food, following a request from the Commission, is currently working to establish upper safe levels for vitamins and minerals based on scientific risk assessment. On the basis of these upper levels and taking into account certain other parameters, maximum levels of vitamins and minerals in foods to which they have been added should be set in order to ensure that the consumption of these foods in the context of a diversified diet will not result in any risk for the consumer. Therefore intakes from all potential food sources, including those naturally present in foods and food supplements, should be taken into account. It should be noted, however, that it is not possible to fortify all foods. This may be due to technological reasons that render addition of vitamins and minerals impossible or would result in products that would not be appealing to the consumer because of the resulting taste, colour, odour or consistency. For others the costs involved would be dissuasive. The population reference intakes or safe and adequate intakes established by the Scientific Committee for Food in 1992 and, more recently, by other authoritative scientific bodies should also be given due consideration. For some vitamins and minerals the amounts that could be permitted to be added, potentially to a wide range of foods, would be limited by safety considerations. Allowing their addition to all foods, on the basis of energy (calorie) content or specific quantity of weight or volume, could result in allowing only insignificant amounts to be added in the different foods. This would be misleading for the consumer and jeopardise the nutritional value of some traditional substitute foods (e.g. margarine) or others that have become an important part of certain meals (e.g. breakfast cereals). It might be therefore necessary in such cases to preferentially limit the addition of a certain vitamin or mineral to only one or a few products or categories of products, taking into account the importance of their contribution to the intake of the vitamin or mineral by the population. Given the technical and complex nature of setting these maximum levels it is appropriate that they should be adopted through the procedure of the Regulatory Committee when all the technical and scientific data become available.
21. In recent years we note the increasing appearance in the composition and labelling of foods of substances or ingredients other than vitamins and minerals that are used in an "innovative" way. The majority of these substances or ingredients are used on the basis of adequate scientific data supporting a demonstrated or plausible beneficial effect and have permitted the food industry to put forward innovative products for an increasingly health conscious and demanding consumer. The use of certain substances or ingredients though is increasingly cause for concern. This is largely due to the absence of sufficient scientific data to demonstrate that their use in large quantities, often far in excess of the quantities in which these substances would be ingested with a normal diet, do not pose any risks to health. These substances or ingredients would not fall under the scope of Regulation (EC) 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients. Sometimes their use and presentation in the labelling may lead to questions as to whether they should be treated as ingredients used in the manufacture of foods or whether they should be considered as "added". Irrespective of the answer to this question, it would be opportune to regulate the safe use of such substances or ingredients, and where necessary prohibit their use, under this proposed Regulation.
22. In conclusion, the proposed rules would contribute to a high level of protection of human life and health and promote the protection of consumer interests by ensuring that the marketed foods to which vitamins and minerals are added or in which certain ingredients are used, are safe and labelled in an adequate and clear manner, allowing consumers to make informed choices. Thus they would be in line with the general principles and requirements of food law as stipulated in Articles 5-8 of the recently adopted Regulation (EC) 178/2002 of the European Parliament and of the Council and with Article 153 of the Treaty. They would also take into account the importance for the food industry to have a regulatory environment that will allow them to innovate and remain competitive at Community and international level. Finally, they would allow monitoring and the possibility to take action if a risk to health or other consumer interests was to appear.