C-192/01

COMMISSION v DENMARK

OPINION OF ADVOCATE GENERAL MISCHO delivered on 12 December 2002 1

1. The Commission of the European Com- itself being a food or a usual ingredient of munities asks the Court to declare that, by compound foods, is intended to be added to applying an administrative practice foods in order to modify their nutritional whereby enriched foodstuffs which are value, their shelf-life, consistency, colour, lawfully produced or marketed in other taste or flavour, or for technical or other Member States may be marketed in Den- purposes.' mark only if there is a documented need for enrichment of food substances in the Dan- ish population, the Kingdom of Denmark has failed to fulfil its obligations under Article 28 EC. 3. Under Article 15(1) of that Law, only substances authorised by the Minister of Food may be used or sold as additives.

I — Legal background 4. According to Article 15(2) of the Law, the Minister may draw up rules relating to the conditions of use of additives, inter alia the aim, the quantities and the products 2. Article 14 of the lov n° 471 ora fød- with which they are associated, as well as evarer m.m. (the Danish Foodstuffs Law) of rules relating to the identity and purity of 1 July 1998, which replaced Law No 310 additives. of 6 June 1973, leaving the law on additives unchanged, provides that:

5. Under Article 16( 1 ) of the same Law, the Minister may draw up rules providing for 'Within the meaning of this Law, a food the possibility of certain groups of specified additive is any substance which, without additives (bacterial cultures, moulds and yeasts, enzymes and nutrients) being used after expiry of a period, fixed by the 1 — Original language: French. Minister, which may be up to six months

— the addition relates to foodstuffs that constitute a meal in themselves or are intended as special-purpose foods (for — the addition of the additive is required example, breast milk substitutes, baby to correct (or prevent) a situation foods or slimming products).

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II — Facts and pre-litigation procedure 12. Despite the absence of a specific instance of the Kingdom of Denmark refus- ing to allow marketing of a foodstuff lawfully marketed in another Member State, the Commission sent a letter of formal notice calling into question the general administrative practice followed 9. In 1998, a complaint was made to the by the Danish authorities with regard to Commission about obstacles to marketing the addition of nutrients to foods. Accord- Ocean Spray Cranberry, a soft drink. The ing to the Commission, it is indisputable complainant had been refused marketing that the Food and Veterinary Office inter- authorisation by the Danish Food and prets these provisions as prohibiting the Veterinary Office. The product contained addition of nutrients, and inter alia vit- added vitamin C. amins and minerals, to foods, unless there is a nutritional need for these substances in Denmark.

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product, since this task is impossible in the principle of proportionality, it is not existing circumstances. They conclude from enough for Member States to establish the this that M e m b e r States, in order to absence of a real need for enrichment with observe the principle of proportionality, nutrients in their population'. have only to show that the enrichment of foodstuffs does not meet a real need.

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the relevant product, a task which is 18. The Commission claims that the Court impossible under existing circumstances. should: In the Danish authorities' view, in order to ensure observance of the principle of proportionality, Member States have only to show that the addition of the nutrient in question does not meet a real need. Accord- ing to the Danish authorities, the scientific uncertainties that existed at the time of the '— declare, pursuant to Article 226 EC, Sandoz judgment have been in no way that, by applying an administrative dispelled since then. On the contrary, new practice whereby enriched foodstuffs knowledge and new proofs continue to which are lawfully marketed and pro- come to light regarding the harmfulness of duced in other Member States may be consuming vitamins and minerals in higher marketed in Denmark only if there is a doses than those found in a normal diet. It documented need for enrichment of is these scientific uncertainties regarding food substances in the Danish popu- the consequences of the addition of vit- lation, the Kingdom of Denmark has amins and minerals that form the basis of failed to fulfil its obligations under the Danish provisions, which, according to Article 28 EC; the Danish authorities, comply with the precautionary principle laid down in the Commission Communication of 2 February 2000 (COM(2000) 1). Finally, the Danish authorities claimed that it is impossible to apply less radical measures, such as label- ling, because there is insufficient knowl- — order the Kingdom of Denmark to pay edge of the actual composition of people's the costs of the proceedings'. diets, and that, furthermore, labelling would be likely to have the negative effect of encouraging the consumer to buy the product.

20. The parties do not deny that the prac- B — justification for the obstacle to free- tice based on the Danish Foodstuffs Law dom of movement constitutes an obstacle to freedom of movement. 1. Summary of the parties' submissions

2 1 . The Commission has rightly pointed 2 4 . During the proceedings before the out that the prohibition on enrichment with Court, the parties gave further details of vitamins relates to requirements affecting their positions as follows. the product's 'composition' and, con- sequently, constitutes an obstacle to intra- Community trade. 3

25. The Commission considers that the contested Danish practice uses as its sole criterion the nutritional need for an addi- tive even though that criterion does not 22. Similarly, the Danish Government, constitute a ground accepted under placing the significance of the effects of its Article 30 EC. practice on freedom of movement in con- text, recognises that this practice '... con- stitutes... an obstacle to the sale of products to which nutrients have been added which are not justified from a nutritional point of 26. Referring to the Court's judgment in view'. Van der Veldt 4 and to the judgment of the Court of the European Free Trade Associ-

3 — See, inter alia, Joined Cases C-267/91 and C-268/91 Keck and Mithouard [1993] ECR I-6097, paragraph 15, and Case C-217/99 Commission v Belgium [2000] ECR I-10251, 4 — Case C-17/93 Van der Veldt [1994] ECR I-3537, para- paragraph 16. graphs 17 to 21.

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27. According to the Commission, the prohibition on enrichment with vitamins 30. It again refers to paragraph 19 of the requires the Member State to carry out a judgment in Sandoz from which it follows, full risk analysis of the health consequences it claims, that Member States are not of the addition of certain vitamins to required to establish the existence of a real specific foodstuffs. The fact that there is a clanger relating to a given product. risk linked to the intake of certain vitamins, such as vitamins A, B or B6, does not justify a general prohibition on enrichment of foodstuffs in cases other than those covered by the Codex Alimentarius. 31. Specifically, the Danish Government maintains that 'the Court, in paragraph 19 of its judgment in Sandoz, found that, where they maintain a prohibition on the addition of vitamins, Member States arc not required to establish the existence of a real danger relating to a given product, since this is an impossible task in the 28. According to the Danish Government, current state of science'. the Danish prohibition is justified specifi- cally by the fact that there is a potential health risk, inasmuch as nutrients are added to foodstuffs when there is no corresponding 'nutritional need' in the population. Nutritional need is used as a criterion for determining whether the addi- 32. In addition, the Danish Government, tion of vitamins and minerals is acceptable referring to the case of Commission v from a public-health point of view. France, 6maintains that a national auth- ority may refuse to authorise the use of an

37. However, since the Commission has 34. For my part, I have already had occa- pointed out the importance of a risk sion to examine this question in my analysis in allowing a Member State to rely Opinion of 16 May 2002 in the case of on the plea of health protection, I shall, Greenham and Abel. 7 secondly, examine the implications for this case of such an approach.

35. There are two extreme positions, which are, firstly, the position that the absence of nutritional need can justify an obstacle to freedom of movement independently of any (b) Analysis from the point of view of the health-protection consideration — a pos- Sandoz judgment ition that might possibly be inferred from a literal reading of the judgment in Commis-

7 — Case C-95/01 Ministère public v Greenham and Abel, 38. Having regard to the importance of judgment of 5 February 2004, not published in the ECR. Sandoz for this case, it seems to me

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law permits national rules prohibiting 42. I cannot accept the interpretation that without prior authorisation the mar- the Commission is thereby putting on the keting of foodstuffs lawfully marketed Sandoz judgment. in another Member State to which vitamins have been added, provided that the marketing is authorised when the addition of vitamins meets a real need, especially a technical or nutri- tional one.' 4 3 . Firstly, it is true that nutritional need can never be, independently of any public- health consideration, a criterion justifying a prohibition on freedom of movement.

39. The parties interpret paragraph 20 of the Sandoz judgment in different ways.

44. In pointing out, in paragraph 18 of Sandoz, that '... national rules providing for such a prohibition are justified only if authorisations to market are granted when they are compatible with the need to protect health', the Court has clearly shown 40. According to the Danish Government, that the context of its analysis is that of 'that judgment... contains a finding that, to public-health protection. 8 observe the principle of proportionality, it is enough to authorise marketing only when the addition meets a real need to enrich the food'.

49. In other words, if the additive meets a nutritional or technical need, the prohib- ition on freedom of movement is not justified. On the other hand, if it does not 46. Thus, it is apparent from the relation- meet such a need, the Member State is ship between paragraphs 19 and 20 that the entitled to take the safer route and to nutritional-need criterion comes into play prohibit marketing of the foodstuff incor- only in a context of scientific uncertainty porating that additive, 1 1in exercise of the with regard to the health risk posed by an broad discretion which the Court acknowl- additive. edges the Member State as having in cases where there is scientific uncertainty.

47. Contrary to what the Commission maintains, I am of the view that, once that 50. Therefore, the nutritional-need cri- scientific uncertainty has been found to terion does not supplant the healthprotec- exist, the Sandoz judgment does allow tion criterion. What the Court has done in Member States to prohibit foodstuffs to its judgment in Sandoz is to clarify, in which the additive in question has been paragraphs 19 and 20, the way in which added, unless its addition meets a nutri- the health-protection justification, as noted tional need. in paragraph 18, is to be understood where there is scientific uncertainty as to the health risk posed by an additive. In that sense, this judgment seems to me to con- stitute an application of the precautionary principle before the fact. 12

56. The Commission, for its part, does not 52. I take the view that it is. challenge the studies to which the Danish Government refers. It simply points out that it has no knowledge of any scientific data which enable it to take the view that excessive vitamin C consumption in itself entails a risk to public health. However, the Danish Government has replied, referring 53. It is, of course, true that, in its judg- to scientific studies, that one of the effects ment in Sandoz, the Court did not hold of vitamin C, that of promoting the once and for all that there is scientific absorption of iron in the digestive tract, uncertainty as to the health risk posed by entails a risk to people who have large adding vitamins to foodstuffs. concentrations of iron, which, in their turn, are associated with a higher risk of cardio- vascular diseases and of cancer.

54. However, the Danish Government refers to a long series of scientific studies on the addition of vitamins and minerals to foodstuffs; these, according to that govern- 57. It is true that, when questioned at the ment, highlight the harmful effect of vit- hearing as to whether the scientific uncer- amins and minerals not only in high doses tainty regarding the harmfulness of adding but also where combinations of vitamins vitamins to foodstuffs, as found by the and minerals are present in relatively low Court nearly 20 years ago, persists today, doses. the Commission replied that developments in research since the early 1980s have made it easier for safety margins to be set for vitamins and minerals.

'Excessive intake of vitamins and minerals 1 3— OJ 2002 L 183, p. 51. may result in adverse effects and therefore

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[this risk] necessitate[s] the setting of maxi- nutrients and by all groups of the popu- mum safe levels for them in food supple- lation across the Community. ments, as appropriate. Those levels must ensure that the normal use of the products under the instructions of use provided by the manufacturer will be safe for the consumer'. 14 Consumers, because of their particular lifestyles or for other reasons, may choose to supplement their intake of some nutrients through food supplements'.15

64. Secondly, the Community legislature itself introduces the concept of nutritional need into the debate about adding vitamins and minerals to foodstuffs, taking the view 66. The Community legislature therefore that the average consumer has no need for seems to be starting from the principle that, additional intake of vitamins and minerals if the general nutrition of the population or and that this need exists only for certain of a part of the population must be population groups. enriched, this must be done through food supplements identifiable as such and not through 'ordinary' foodstuffs.

65. The third and fourth recitals of Direc- tive 2002/46 state as follows: 67. Finally, it should be noted that the Danish practice is based on the 'General Principles for the Addition of Essential Nutrients to Foods' adopted by the Codex Alimentarius Committee in 1987 and amended in 1989 and 1991. 1 6

'3.1 Essential nutrients may be added to foods for the purpose of: 70. The Introduction to the General Prin- ciples informs us that they are intended, among other things, 'to prevent the indis- criminate addition of essential nutrients to foods thereby decreasing the risk of health 3.1.1 restoration; hazard due to essential nutrient excesses, deficits or imbalances. This will also help to prevent practices which may mislead or deceive the consumer'. 18

3.1.2 nutritional equivalence of substitute foods;

71. The section relating to definitions then states, as follows:

3.1.3 fortification;

'2.5 Fortification or enrichment means the addition of one or more essential

17 — Case 247/84 Motte [1985] ECR 3887, paragraph 24; Case 3.1.4 ensuring the appropriate nutrient 304/84 Muller and Others [1986] ECR 1511. paragraph composition of special purpose food. 24; Case 178/84 Commission v Germany ('Beer') [1987] ECR 1227, paragraph 44; Case C-42/90 Belimi ¡1990 ECR I-4863, paragraph 14, and Joined Cases CM 3/91 and C-113/91 Debus [1992] ECR I-3617, paragraph 17. 18 — Emphasis added. 19 — Emphasis added.

74. Taking all the above into account, I am 6.2 The following conditions should be of the view that there is no reason to fulfilled for any fortification pro- consider that adding vitamins to ordinary gramme: foodstuffs appears to be a more reliable

20 — Emphasis added. 21 — Emphasis added.

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exercise from a scientific point of view than (c) Examination of the issue from the point it was 20 years ago when the Court of view of risk analysis delivered its judgment in Sandoz.

22 — See, inter alia, the 13th recital. 23 — Emphasis added.

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81. It therefore appears that each of the Member State to carry out a full risk parties has chosen its approach in order to analysis of the health consequences of the defend its view — the Danish Government addition of certain vitamins to food- taking the approach resulting from the stuffs'. 2 6 Sandoz judgment and the Commission the approach resulting from the EFTA Court's judgment — and that in their eyes these two approaches are irreconcilable.

86. That judgment had its origin in a refusal by the Norwegian authorities to authorise the marketing of corn flakes 82. But are they really? enriched with certain vitamins and with iron. The reason for that refusal was the absence, within the Norwegian population, of a nutritional need for such enrichment.

83. I have already indicated, referring for support to the legal literature, that, in my view, Sandoz is an application of the precautionary principle before the fact. 2 4 87. The EFTA Court found that there was Other commentators, too, also place the a failure to fulfil obligations laid down in Sandoz judgment in a risk analysis con- Article 11 of the Agreement on the Euro- text. 2 5 pean Economic Area, for two reasons:

the addition of iron to foodstuffs had 90. Explicit references to risk analysis can been carried o u t . 2 8 be found, for example, in the Commission's Communication of 2 February 2000 on the precautionary principle; 3 0 in Common Position (EC) No 2/2002 of 17 September 2001 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to 88. The first of the two reasons above is adopting a Regulation (EC) of the Euro- not obviously relevant to the present case, pean Parliament and of the Council laying since the factual situation is not the same. down the general principles and require- The second requires a better understanding ments of food law, establishing the Euro- of the concept of 'comprehensive risk pean Food Authority and laying down assessment' and, in particular, the relation- procedures in matters of food safety;31at ship of that concept to that of 'risk the international level, in the Cartagena analysis'. Protocol on Biosafcty to the Convention on Biological Diversity, 3 2 approved by the Council on behalf of the European Com- munity, by Decision 2002/628/EC; 3 3and, most recently judgments of the Court of First Instance in Pfizer Animal Health v Council34 and Alpharma v Council.35

95. With regard to the 'political' stage — that is, establishing the level of risk deemed acceptable — the Court of First Instance pointed out that: 93. The Court of First Instance has ana- lysed these two stages in detail in its judgments in Pfizer Animal Health v Council and Alpbarma v Council. '... it is for the Community institutions to determine the level of protection which they deem appropriate for society. It is by reference to that level of protection that they must then... determine the level of risk — i.e. the critical probability thresh- 94. As regards the 'scientific' stage — risk old for adverse effects on human health and assessment in the strict sense — the Court for the seriousness of those possible of First Instance held that 'scientific risk effects — which in their judgment is no assessment is commonly defined, at both longer acceptable for society and above international level... and Community which it is necessary, in the interests of level..., as a scientific process consisting in protecting human health, to take preventive the identification and characterisation of a measures in spite of any existing scientific hazard, the assessment of exposure to the uncertainty (see, to that effect, Case hazard and the characterisation of the C-473/98 Toolex [2000] ECR I-5681, risk' 38 and that 'the competent public paragraph 45). Therefore, determining the authority must, in compliance with the level of risk deemed unacceptable involves relevant provisions, entrust a scientific risk the Community institutions in defining the political objectives to be pursued under the powers conferred on them by the Treaty. 36 — Thus, although determination of the level of risk deemed unacceptable is viewed by the Court of First Instance as formine part of the risk assessment stage (see Pfizer Animal Health v Council, paragraph 149, and Alpbarma v Council, paragraph 162), commentators consider that it forms part of the risk management stage (see Noiville, C , and de Sadeleer, N., loc. cit., p. 400, and Alemanno, A., loc. cit., p. 936). See also de Sadeleer, N., 'Le statut juridique du principe de précaution en droit communaut- Although they may not take a purely aire: du slogan à la règle', Cahiers de droit européen, 2001, E. 91, 105: '... the division advocated by the Commission hypothetical approach to risk and may etween risk assessment and the policy making that follows — risk management — is blurred by the constant not base their decisions on a "zero-risk"..., push and pull between facts and values, nature and culture, science and politics'. 37 — See also Alemanno, A., loc. cit., p. 937. 38 — Pfizer Animal Health v Council, paragraph 156, and 39 — Pfizer Animal Health v Council, paragraph 157, and Alpharma v Council, paragraph 169. Alpbarma v Council, paragraph 170.

42 — Case C-121/00 Hahn [2002] ECR I-9193. 43 — According to the Commission's Communication on the precautionary principle, paragraph 3, 'when there are reasonable grounds for concern that potential hazards may 98. Furthermore, this Court very recently affect the environment or human, animal or plant health, and when at the same time the available data preclude a held, in paragraph 47 of its judgment in detailed risk evaluation, the precautionary principle has been politically accepted as a risk management strategy in several fields' (emphasis added). 44 — Pfizer Animal Health v Council, paragraph 139, and 40 — Pfizer Animal Health v Council, paragraphs 151 and 152, Alpbarma v Council, paragraph 152. and Alpbarma v Council, paragraphs 164 and 165. 45—Case C-157/96 The Queen v Ministry of Agriculture, Emphasis added. Fisheries and Food, Commissioners of Customs & Excise, 41 — See, inter alia, Sandoz, paragraph 16; Debus, paragraph ex parte National Farmers' Union and Others [1998] ECR 13; Case C-293/94 Brandsma [19961 ECR I-3159, para- graph 11, and Case C-400/96 Harpegnies [1998] ECR I-2211. I-5121, paragraph 33. 46 — Case C-180/96 United Kingdom v Commission [1998] ECR I-2265. I - 9715

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until the reality and seriousness of those taken only if the risk, although the reality risks become fully apparent', 4 7 held as and extent thereof have not been "fully" follows: demonstrated by conclusive scientific evi- d e n c e , a p p e a r s n e v e r t h e l e s s t o be adequately backed up by the scientific data available at the time when the measure was taken'. 4 8

48 — Pfizer Animal Health v Council, paragraphs 142 to 144, and Alpharma v Council, paragraphs 155 to 157. 49 — See also Salmon, N., 'A European perspective on the In contrast, it follows from the Community precautionary principle, food safety and the free trade Courts' interpretation of the precautionary imperative of the W T O ' , European Law Review, 2002, p. 138, which contains the following: 'Risk is measured principle that a preventive measure may be not only by positive knowledge of a quantifiable likeli- hood, but also by the degree of uncertainty or lack of knowledge about a possible hazard.... On the continuum between a merely speculative risk and a conclusively demonstrated one lies a vast stretch of undemonstrated, 4 7 — National Farmers' Union and Others, paragraph 6 3 , and unquantified but scientifically plausible risks. Within that United Kingdom v Commission, paragraph 99. zone, the risk of harm is real so long as safety is unproven'.

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Member State to adopt measures on the public health. Nevertheless such a risk basis of Article 30 EC. Moreover, the cannot be excluded in so far as the greater the scientific uncertainty, the consumer absorbs with other foods further broader the discretion of the Member quantities of vitamins which it is impossible States, which are responsible for protecting to monitor or foresee'.50 public health.

103. In the light of these considerations concerning the concept of 'risk analysis', 107. Therefore, there was a plausible risk, has the Sandoz judgment become obsolete? linked to excessive consumption of vit- amins. However, according to paragraph 19 of the Sandoz judgment, the degree of that risk was not certain. Nevertheless, the Court upheld, in paragraph 20, the prohib- ition on marketing of foodstuffs, lawfully 104. I take the view that it has not. marketed in another Member State, to which the vitamin was added, while mak- ing that prohibition dependent on absence of nutritional need.

114. The Commission has again replied, however, that 'assessment by Member States of the risk to public health must rely 111. Furthermore, that characterisation of on concrete scientific evidence of the risk nutritional need as a risk-management presented by the addition of each type of criterion seems to me to be strengthened vitamin in particular. 52 The Commission by Common Position N o 2 / 2 0 0 2 , referred, at the hearing, to the Opinion of Article 6(3) of which states, as follows: Advocate General Geelhoed of 16 May 2002 in the cases of Commission v Ger- many and Commission v Austria. 53

'Risk management shall take into account the results of risk assessment, and in 115. That Opinion concerns a different particular, the opinions of the Authority issue, namely whether all preparations with referred to in Article 22, other factors added vitamins containing three times the legitimate to the matter under consider- recommended daily dose could automati- ation and the precautionary principle when cally be viewed as medicinal products. the conditions laid down in Article 7(1) are relevant'. 51

116. I share the view expressed by Advo- cate General Geelhoed, that, in principle, there should be a case-by-case examination, 112. Even though the nutritional-need cri- but that one can also 'imagine situations in terion might not already have been taken which general regulations could be accept- into consideration under the precautionary able in relation to certain groups or cat- principle, it should at least be able to be egories of products. This is particularly so taken into account as 'a factor legitimate to the matter under consideration'. 52 — Emphasis added. 53 — Cases C-387/99 Commission v Germany and C-150/00 Commission v Austria, judgment of 29 April 2004, not 51 — Emphasis added. published in the ECR.

54 — Paragraph 63 of the Opinion. 55 — Case 227/82 Van Bennekom [1985] ECR 3883.

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123. Nor are Member States obliged to by a national authority of the absence of a allow marketing of an enriched foodstuff nutritional need will not justify an import solely because another Member State has ban, a most restrictive measure, on a taken the view that it was already in a product which is freely traded in other position to make that determination. 56 In EEA States'. the absence of harmonisation, each Member State is entitled to decide the level at which it wishes to protect human health.

127. However, the EFTA Court had also previously pointed out that: 124. It is impossible to see, therefore, why a Member State could not, where there is a plausible risk, the degree of which cannot be established with certainty, decide to adopt as the safety limit, the level of nutritional need of its population, which 'The need to safeguard public health has it will have determined on the basis of the been recognised as, and remains, a primary population's food habits or which cor- concern, and the level of protection chosen responds to the level at which absence of by the Contracting Parties should not be danger is presumed. placed in question. However, the principle of proportionality must be respected.

125. It is true that the Commission takes the view that '[the] prohibition on market- In that process, the question of nutritional ing foodstuffs to which vitamins have been need with regard to additives to foodstuffs added is contrary to the principle of pro- in any given population may have a proper portionality as established in the case-law place....'.58 of the Court'. 57 Here, the Commission is referring to paragraph 28 of the EFTA Court's judgment.

134. For its part, the Commission seems to be conceding that the mention of vitamin content on the packaging could be accom- panied by a warning. 131. On this same issue of proportionality, the Commission again takes the view that appropriate labelling of foodstuffs offers a replacement solution that is more propor- tionate to the objective envisaged than that of preventing the free movement of the products concerned. 135. In my view, such a warning should be of the following type: 'Attention, consump- tion of this foodstuff can harm your health if your regular diet already includes all the vitamins and minerals your body needs. This risk is greater still if you consume 132. In that regard, I would first point out other foodstuffs enriched with vitamins and that, in its judgment in Sandoz, the Court minerals'. did not adopt that solution since it did not consider a prohibition on freedom of movement to be a disproportionate meas- 59 — Case C-320/93 Ortscheit [1994] ECR I-5234, paragraph ure. In this context, moreover, it should be 16.

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136. However, it is immediately apparent who therefore do not receive their quota of that such a warning would be more a nutrients through their daily diet. source of confusion than anything else. Furthermore, the average, even reasonably well-informed, consumer would have a great deal of difficulty in assessing the total vitamins and minerals he is already absorb- ing. 140. It seems to me, therefore, that the possible prohibition on marketing to which the contested Danish practice could lead would not be disproportionate to the objective of health protection which that practice seeks to attain.

138. However, the Danish Government has, rightly in my view, replied that the sale of vitamins in supermarkets is an entirely different situation, which must 142. For all these reasons, I have reached not be confused or muddled with the sale the conclusion that the Danish Govern- of basic foodstuffs. ment's practice of granting marketing auth- orisation to an ordinary foodstuff enriched with vitamins or minerals only if the food- stuff falls into one of the categories in respect of which the Codex Alimentarius provides for such enrichment and only if its level of enrichment is justified by the 139. The fact is that food supplements and nutritional needs of Denmark's population, vitamin preparations are not viewed by is justified by the need to protect public consumers as foods and they are not health as provided for in Article 30 EC and consumed as such. They are products that the practice is proportionate to that which are the subject of an active approach aim. on the part of the consumer, in view of their supposed effect. They are a useful instrument for reaching population groups 60 — The Commission has not, of course, at any time main- tained that the Kingdom of Denmark is seeking to protect with specific nutritional needs, those who enriched foodstuffs produced in its territory from the competition of foodstuffs originating in or coming from eat little or who have difficulty eating, and other Member States.

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143. That practice meets the conditions 145. Finally, the fact that other Member laid down by the Sandoz judgment, con- States apply a less rigorous policy does not ditions which are, in my view, compatible call into question the validity of this with those that arise from applying risk- reasoning. The rules governing the free analysis theory. movement of goods must not lead to health protection standards in the Community being levelled down.