CELEX: 62002CJ0041
Language: en
Date: 2004-12-02
Title: Judgment of the Court (Third Chamber) of 2 December 2004. # Commission of the European Communities v Kingdom of the Netherlands. # Failure of a Member State to fulfil obligations - Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 EC and 30 EC) - Foodstuffs to which vitamins or mineral salts have been added - National legislation making their marketing subject to there being a nutritional need - Measures having equivalent effect - Justification - Public health - Proportionality. # Case C-41/02.

Case C-41/02
      Commission of the European Communities
      v
      Kingdom of the Netherlands
      (Failure of a Member State to fulfil obligations – Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 EC and 30 EC) – Foodstuffs to which vitamins or mineral salts have been added – National legislation making their marketing subject to there being a nutritional need – Measures having equivalent effect – Justification – Public health – Proportionality)
      Summary of the Judgment
      Free movement of goods – Quantitative restrictions – Measures having equivalent effect – National legislation systematically
            making the marketing of foodstuffs to which vitamins or mineral salts have been added subject to there being a nutritional
            need in the population – Not permissible – Justification – Protection of public health – None – Infringement of the principle
            of proportionality
      (EC Treaty, Arts 30 and 36 (now, after amendment, Arts 28 EC and 30 EC))
      A Member State which applies an administrative practice under which foodstuffs for everyday consumption fortified with vitamin
         A (in the form of retinoids), vitamin D, folic acid, selenium, copper or zinc which are lawfully produced or marketed in other
         Member States may be marketed on its territory, when they are neither substitution products nor reconstituted foodstuffs within
         the meaning of the national legislation, only if that enrichment meets a nutritional need in the population of that Member
         State and, in addition, without ascertaining whether those fortified foodstuffs might be a substitute for foodstuffs already
         marketed for which the addition of those nutrients is mandatory, fails to fulfil its obligations under Article 30 of the EC
         Treaty (now, after amendment, Article 28 EC).
      
      Community law does not preclude legislation of a Member State prohibiting in accordance with the precautionary principle,
         save for prior authorisation, the marketing of foodstuffs when nutrients other than those whose addition is lawful under that
         legislation have been added thereto, because it is for the Member States, in the absence of harmonisation and to the extent
         that uncertainties continue to exist in the current state of scientific research, to decide on their intended level of protection
         of human health and life; that discretion must, however, be exercised in accordance with the principle of proportionality.
         Furthermore, it is for the national authorities to show in each case, in the light of national nutritional habits and in the
         light of the results of international scientific research, that their rules are necessary to safeguard public health and,
         in particular, that the marketing of the products in question poses a real risk for public health.
      
      In those circumstances, the systematic prohibition on the marketing of fortified foodstuffs, as it results from the administrative
         practice in the Member State concerned, does not enable Community law to be observed in regard to the identification and assessment
         of a real risk for public health, which requires a detailed assessment, case by case, of the effects which the addition of
         the minerals and vitamins in question could entail.
      
      (see paras 42, 44, 46-47, 63, 70, operative part)

      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
            
            JUDGMENT OF THE COURT (Third Chamber)2 December 2004(1)
         
         
            
         
               (Failure of a Member State to fulfil obligations  –  Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 EC and 30 EC)  –  Foodstuffs to which vitamins or mineral salts have been added  –  National legislation making their marketing subject to there being a nutritional need  –  Measures having equivalent effect  –  Justification  –  Public health  –  Proportionality)
               
             In Case C-41/02,ACTION under Article 226 EC for failure to fulfil obligations, brought on 13 February 2002,
            
            
            Commission of the European Communities, represented by H. van Lier and H.M.H. Speyart, acting as Agents, with an address for service in Luxembourg, 
            
            
            applicant,
            
            v
            Kingdom of the Netherlands, represented by H.G. Sevenster and S. Terstal, acting as Agents,
            
            defendant,
            
            
            THE COURT (Third Chamber),,
            
             composed of: A. Rosas, President of the Chamber, A. Borg Barthet, J.-P. Puissochet, J. Malenovský (Rapporteur) and U. Lõhmus,
            Judges, 
            
             Advocate General: M. Poiares Maduro, Registrar: H. von Holstein, Deputy Registrar,
             having regard to the written procedure and further to the hearing on 14 July 2004,
            
            after hearing the Opinion of the Advocate General at the sitting on 14 September 2004,
         gives the following
         
         
         Judgment
         1
            
          By its application, the Commission of the European Communities seeks a declaration from the Court that, first, by adopting
         and maintaining in force in its legislation Article 10(1) of the Warenwetbesluit Bereiding en behandeling van levensmiddelen
         (Decree implementing the Warenwet [Commodities Law], on the preparation and treatment of foodstuffs) of 10 December 1992 (Stb.
         1992, 678) (‘the BBL Decree’), and subsequently Articles 2(1) and 5 of the Warenwetbesluit Toevoeging micro-voedingsstoffen
         aan levensmiddelen (Decree implementing the Warenwet, on the addition of micronutrients to foodstuffs) of 24 May 1996 (Stb.
         1996, 311) (‘the TML Decree’), and secondly by applying a derogation scheme under which, where applicable, account is not
         taken of the substitutability of certain fortified food products, with the result that food products lawfully prepared and
         marketed in another Member State, fortified with vitamin A (in the form of retinoids), vitamin D, folic acid, selenium, copper
         or zinc, which are not substitution products or reconstituted products within the meaning of the TML Decree may not be marketed
         in the Netherlands unless that addition does not pose a risk for public health and meets an actual nutritional need, the Kingdom
         of the Netherlands has failed to fulfil its obligations under Articles 30 and 36 of the EC Treaty (now, after amendment, Articles
         28 EC and 30 EC).
         
         
         
         2
            
          By order of the President of the Court of 30 July 2002, the Kingdom of Denmark was granted leave to intervene in support of
         the forms of order sought by the Kingdom of the Netherlands but, by letter received at the Court Registry on 21 July 2004,
         it advised that it would not intervene.
         
         
            
               Legal framework
            Community rules
         
         3
            
          It is common ground that, on the date relevant for this action, that is, at the end of the two-month period given in the supplementary
         reasoned opinion of 21 December 1998, referred to in paragraph 20 of this judgment, Community legislation did not contain
         any provisions governing the addition of nutrients such as vitamins and minerals to foodstuffs used for everyday consumption.
         
         
         
         4
            
          As regards foodstuffs intended for particular nutritional uses, some of them are governed by directives adopted by the Commission
         on the basis of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating
         to foodstuffs intended for particular nutritional uses (OJ 1989 L 186, p. 27). 
         
         National rules 
         
         5
            
          The manufacture and the marketing of food products are governed in the Netherlands by the Wet van 28 december 1935 houdende
         voorschriften betreffende de hoedanigheid en aanduiding van waren (Law of 28 December 1935 on the classification and designation
         of goods, Stb. 1935, 793), in the version applicable at the relevant date for the present action (‘the Warenwet’).
         
         
         
         6
            
          Under Article 4(1) of the Warenwet, for the purpose of prohibiting goods which, in the course of normal use, may pose a risk
         for health or safety, the competent authority may, by administrative regulation, prohibit the preparation, manufacture, marketing
         or processing and use for purposes specified in that regulation of foodstuffs belonging to a category designated by that regulation
         which do not meet the requirements laid down by the regulation as to composition, manufacture, or qualities and properties.
         
         
         
         
         7
            
          Article 16(1) and (2) of the Warenwet provides:
         ‘1.     The Minister may, in relation to goods belonging to a category designated in his decision, grant an exemption from the rules
         following from the application of any of Articles 4 to 15.
          2.       The Minister may also, in relation to goods belonging to a category designated in the corresponding decision, grant, on request,
         a derogation from those rules. …’
         
         
         
         8
            
          Article 10 of the BBL Decree provided, in its original version:
         ‘1.     Foodstuffs shall not contain vitamins, fluoride or iodine compounds, amino acids or salts thereof, unless those substances
         are naturally present in them in the same composition and the same quantity. 	
          2.       Paragraph 1 shall not apply to foodstuffs covered by legal provisions providing otherwise.’
         
         
         
         9
            
          Paragraph 2 of that article has since been amended, with effect from 26 June 1996, by Article 10 of the TML Decree and now
         reads as follows:
         ‘Paragraph 1 shall not apply
         
         (a)
            to fortified foodstuffs as referred to in [the TML Decree], as regards the presence of vitamins;
         
         
         (b)
            to foodstuffs covered by legal provisions providing otherwise.’
         
         
         
         
         10
            
          Article 1(1)(a) to (d) of the TML Decree provides:
         ‘The following definitions shall apply for the purposes of the present Decree:
         
         (a)
            micronutrients: nutrients which are indispensable for the functioning of the human organism which that organism cannot provide
               by itself and which must be consumed in small quantities;
            
         
         
         (b)
            fortified foodstuffs: a foodstuff supplemented with one or more micronutrients, but the primary purpose of which is not to
               provide micronutrients;
            
         
         
         (c)
            substitution product: a fortified foodstuff
         
         
         
          
         
            
               –
                  which is intended to replace an existing product and is as close as possible to it in appearance, consistency, taste, colour,
                     smell and purpose; and
                  
               
         
         
         
         
          
         
            
               –
                  to which one or more micronutrients have been added in proportions not exceeding those in which those substances are naturally
                     present in the foodstuff to be replaced;
                  
               
         
         
         
         (d)     reconstituted foodstuff: a fortified foodstuff 
         
         
         
          
         
            
               –
                  prepared according to the directives relating to good production practices; and
               
         
         
         
         
          
         
            
               –
                  to which one or more micronutrients have been added up to proportions in which those substances were naturally present, before
                     the preparation, in the edible part of the product or in the edible parts of the raw materials of the product but which were
                     lost after or during preparation.’
                  
               
         
         
         
         
         
         11
            
          Under Article 2(1) of the TML Decree, ‘the preparation or marketing of fortified foodstuffs which do not meet the requirements
         as to composition laid down in the present decree shall be prohibited’.
         
         
         
         12
            
          Article 5 of the same decree provides:
         ‘Micronutrients such as vitamin A in the form of retinoids, vitamin D, folic acid, selenium, copper and zinc shall be added
         to a fortified foodstuff solely for the purpose of making it a substitution product or a reconstituted foodstuff.’
         
         
         
         13
            
          Under Article 16(1) and (2) of the Warenwet, the Netherlands Minister for Health may grant an exemption or a derogation from
         the prohibition on marketing of a foodstuff under the TML Decree. Pursuant to Article 23 of the Warenwet, his decision may
         be subject to review by the College van Beroep voor het Bedrijfsleven.
         
         
         
         14
            
          In the case of foodstuffs fortified with micronutrients, the consistent policy of the Netherlands Minister for Health, endorsed
         by the College van Beroep voor het Bedrijfsleven, has been to grant a derogation only where two criteria are satisfied:
         
         
         
          
         –
            the foodstuff to which micronutrients have been added must not per se be harmful to public health;
         
         
         
         
          
         –
            the addition must meet an actual need, in particular nutritional.
         
         
         
         Pre-litigation procedure 
         
         15
            
          The Commission was informed that, in 1995 and 1996, two traders had been refused authorisation to market products in the Netherlands,
         whereas those products were already lawfully being marketed in other Member States: Kellogg’s for its breakfast cereals fortified
         with vitamin D and folic acid and Inkosport Nederland for its energy bars fortified with folic acid. 
         
         
         
         16
            
          Considering those refusals to be contrary to Article 30 of the Treaty, the Commission, by two letters of formal notice of
         26 June 1996, requested the Netherlands authorities to provide explanations on the matter.
         
         
         
         17
            
          Not satisfied with the replies it received from the aforementioned authorities, on 23 September 1997 the Commission issued
         two reasoned opinions to the Kingdom of the Netherlands. The Netherlands authorities replied to those opinions by letters
         of 12 and 18 December 1997.
         
         
         
         18
            
          Meanwhile, the draft decree and then the TML Decree were notified to the Commission pursuant to Council Directive 83/189/EEC
         of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations
         (OJ 1983 L 109, p. 8), as amended by Directive 94/10/EC of the European Parliament and the Council of 23 March 1994 (OJ 1994
         L 100, p. 30).
         
         
         
         19
            
          Following an exchange of letters, the Commission, considering that the scheme for derogating from the marketing prohibition
         went beyond what was necessary for health protection in that it required both that the addition of micronutrients not be harmful
         and that it meet an actual nutritional need, by letter of 22 December 1997 put the Netherlands authorities on formal notice
         to provide explanations on the infringement to which it referred. 
         
         
         
         20
            
          Not satisfied with their response, it issued the Kingdom of the Netherlands with a reasoned opinion by letter of 31 August
         1998, and sent a supplementary reasoned opinion by letter of 21 December 1998. The Netherlands authorities replied to those
         two opinions by letters of 8 September 1998 and 21 April 1999 respectively.
         
         
         
         21
            
          In those circumstances, the Commission decided to bring the present action.
         
         The action
         
         22
            
          It is appropriate to note as a preliminary point that, notwithstanding the wording of the operative part of the application,
         the present action is not directed against the Netherlands rules. Indeed, the Commission states clearly that its action is
         not aimed at the marketing prohibition scheme established by the TML Decree as such. Likewise, it states that it is not raising
         the question of the formal compatibility with Community law of the procedure applicable to applications for derogation.
         
         
         
         23
            
          Thus, the Commission does not contest the obligation imposed on producers or importers of certain fortified foodstuffs to
         obtain a derogation from the prohibition on marketing those foodstuffs as laid down by the Netherlands rules. Its action is
         aimed solely at the practice, referred to in paragraph 14 of this judgment, which consists of the Netherlands authorities
         making the existence of an actual nutritional need a precondition for the granting of such a derogation. That is the subject-matter
         of the action as thus defined and on which the Court is asked to rule. 
         
         The national administrative practice
         
         24
            
          Since the Commission and the Netherlands Government do not agree on the features of the administrative practice in the Netherlands
         with regard to the granting of derogations from the prohibition on marketing certain fortified foodstuffs, it is appropriate,
         as a first step, to ascertain exactly what that practice comprises.
         
         
         
         25
            
          First of all, it is common ground that foodstuffs for everyday consumption which are fortified with vitamin A (in the form
         of retinoids), vitamin D, folic acid, selenium, copper or zinc may be marketed in the Netherlands, when they are not substitution
         products or reconstituted foodstuffs, only where a derogation has been granted from the marketing prohibition resulting from
         the combined provisions of Article 10 of the BBL Decree, as amended, and Articles 2(1) and (5) of the TML Decree.
         
         
         
         26
            
          It is also common ground that that derogation is granted by the Netherlands Ministry of Health only if, first, the foodstuff
         to which one of those nutrients has been added is not harmful to public health and, second, if the addition meets an actual
         nutritional need. Those two criteria are cumulative.
         
         
         
         27
            
          Contrary to the contentions of the Commission, the mere finding that a fortified foodstuff satisfies the first criterion is
         not sufficient to establish that the marketing of that product entails no risk for public health. 
         
         
         
         28
            
          It is apparent from both the explanations of the Netherlands Government and the decisions taken by the competent national
         authorities on previous applications for derogations that the first criterion is met if the fortified foodstuff is not harmful
         per se, that is, if the quantity of the nutrient it contains is not dangerous in itself, regardless of which other sources
         of that nutrient there may be in the diet of the Netherlands population. 
         
         
         
         29
            
          Vitamins and minerals are not as a general rule harmful in themselves but may have special harmful effects if taken to excess
         as part of the general nutrition, the composition of which cannot be foreseen or monitored (see, with respect to vitamins,
         Case 174/82 Sandoz [1983] ECR 2445, paragraph 17; Case C-192/01 Commission v Denmark [2003] ECR I‑9693, paragraph 43; and Case C‑24/00 Commission v France [2004] ECR II‑0000, paragraph 50).
         
         
         
         30
            
          Accordingly, the mere fact that a foodstuff fortified with a given nutrient is not per se harmful to public health, and thus
         fulfils the first criterion, does not necessarily mean that it is free of risk. As pointed out by the Netherlands Government,
         it is still necessary to determine whether it entails a risk for public health having regard to other sources of that nutrient
         in overall food intake.
         
         
         
         31
            
          The Netherlands Government submits that that assessment must be carried out as part of the assessment for the second criterion,
         relating to the existence of an actual nutritional need.
         
         
         
         32
            
          Second, it is apparent from the derogation application procedures which have been dealt with by the competent Netherlands
         authorities that derogation is systematically refused when the fortified foodstuff does not satisfy the second criterion.
         
         
         
         33
            
          The example referred to by the Netherlands Government in order to demonstrate that a derogation may be granted in some cases
         for a fortified foodstuff which does not meet any nutritional need is not relevant. The example given relates to a marketing
         authorisation for margarine fortified with vitamin D, issued in 2002, that is, after the expiry of the time-limit given in
         the supplementary reasoned opinion of 21 December 1998. In addition, in that authorisation procedure, the competent Netherlands
         authorities found that there was a nutritional need for vitamin D among persons aged over 60 and that the marketing authorisation
         was to be subject to the condition that the margarine in question carry a label advising that the product should not be consumed
         by persons under 60 years of age.
         
         
         
         34
            
          Accordingly, the Commission is right to point to the systematic nature of the prohibition on marketing fortified foodstuffs
         which do not meet an actual nutritional need.
         
         
         
         35
            
          Lastly, it is apparent from the derogation application procedures which have been dealt with by the competent Netherlands
         authorities that, contrary to what the Commission maintains, it is for the Netherlands authorities to establish that there
         is no nutritional need in order to refuse a derogation application. Thus the decision of 10 March 1994 of the Netherlands
         Secretary for Welfare, Health and Culture taken in the ‘Punica’ case states that ‘as regards demonstrable need, the (Netherlands
         Health Ministry Claims) Commission finds that the appellant has not sufficiently demonstrated the existence thereof, but that
         the Ministry has plausibly shown that the addition is not necessary’.
         
         
         
         36
            
          Traders will, of course, attempt to show that their product meets such a need, but that does not mean that the burden of proof
         is reversed. 
         
         
         
         37
            
          It is appropriate to consider whether the administrative practice in the Netherlands concerning the granting of derogations,
         as described above, constitutes a measure having effect equivalent to a quantitative restriction on imports and, if so, whether
         it may be justified on the basis of Article 36 of the Treaty, as the Netherlands Government maintains. 
         
         Whether there is a measure having effect equivalent to a quantitative restriction on imports 
         
         38
            
          The free movement of goods between Member States is a fundamental principle of the Treaty, expressed in the prohibition laid
         down in Article 30 of the Treaty on quantitative restrictions on imports between Member States and all measures having equivalent
         effect.
         
         
         
         39
            
          The prohibition on measures having equivalent effect to restrictions set out in Article 30 of the Treaty covers all commercial
         rules enacted by the Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community
         trade (see, in particular, Case 8/74 Dassonville [1974] ECR 837, paragraph 5; Commission v Denmark, paragraph 39; and Commission v France, paragraph 22).
         
         
         
         40
            
          It is not disputed that the Netherlands administrative practice is a measure having effect equivalent to a quantitative restriction
         within the meaning of Article 30 of the Treaty. 
         
         
         
         41
            
          Indeed, that practice, which requires that the marketing of foodstuffs fortified with vitamins and minerals and coming from
         other Member States where they are lawfully manufactured or marketed be subject to proof of a nutritional need in the Netherlands
         population, makes the marketing of such foodstuffs more difficult, if not impossible, and consequently hinders trade between
         the Member States (see, to that effect, Commission v Denmark, paragraph 41). 
         
         The justification based on the protection of public health
         
         42
            
          As regards the question whether the Netherlands administrative practice may be justified on the basis of Article 36 of the
         Treaty, it is for the Member States, in the absence of harmonisation and to the extent that uncertainties continue to exist
         in the current state of scientific research, to decide on their intended level of protection of human health and life and
         on whether to require prior authorisation for the marketing of foodstuffs, always taking into account the requirements of
         the free movement of goods within the Community (see Sandoz, paragraph 16; Commission v Denmark, paragraph 42; and Commission v France, paragraph 49). 
         
         
         
         43
            
          That discretion relating to the protection of public health is particularly wide where it is shown that uncertainties continue
         to exist in the current state of scientific research as to certain substances, such as vitamins, which, as observed in paragraph
         29 of this judgment, are not as a general rule harmful in themselves but may have special harmful effects if taken to excess
         as part of the general nutrition, the composition of which cannot be foreseen or monitored (see Sandoz, paragraph 17; Commission v Denmark, paragraph 43; and Commission v France, paragraph 50).
         
         
         
         44
            
          Community law does not therefore preclude legislation of a Member State prohibiting in accordance with the precautionary principle,
         save for prior authorisation, the marketing of foodstuffs when nutrients other than those whose addition is lawful under that
         legislation have been added thereto (see, to that effect, Commission v Denmark, paragraph 44; and Commission v France, paragraph 51).
         
         
         
         45
            
          It is clear from Article 130r of the EC Treaty (now, after amendment, Article 174 EC) that the protection of human health
         is one of the objectives of the Community policy on the environment, that that policy aims at a high level of protection and
         is to be based inter alia on the precautionary principle, and that the requirements of that policy must be integrated into
         the definition and implementation of other Community policies. In addition, it follows from the case-law of the Court that
         the precautionary principle may also apply in policy on the protection of human health which, according to Article 129 of
         the EC Treaty (now, after amendment, Article 152 EC) likewise aims at a high level of protection (see, to that effect, Case
         C-157/96 National Farmers’ Union and Others [1998] ECR I-2211, paragraphs 63 and 64; Case C-236/01 Monsanto Agricoltura Italia and Others [2003] ECR I-8105, paragraphs 128 and 133; Commission v Denmark, paragraph 49; and Commission v France, paragraph 56; see also, to that effect, Case T-13/99 Pfizer Animal Health v Council [2002] ECR II-3305, paragraphs 139 and 140; Case T-70/99 Alpharma v Council [2002] ECR II-3495, paragraphs 152 and 153; and Case T-177/02 Malagutti-Vezinhet v Commission [2004] ECR II‑0000, paragraph 54). 
         
         
         
         46
            
          However, in exercising their discretion relating to the protection of public health, the Member States must comply with the
         principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure
         the safeguarding of public health; they must be proportional to the objective thus pursued, which could not have been attained
         by measures which are less restrictive of intra-Community trade (see Sandoz, paragraph 18; Commission v Denmark, paragraph 45; and Commission v France, paragraph 52). 
         
         
         
         47
            
          Furthermore, since Article 36 of the Treaty provides for an exception, to be interpreted strictly, to the rule of free movement
         of goods within the Community, it is for the national authorities which invoke it to show in each case, in the light of national
         nutritional habits and in the light of the results of international scientific research, that their rules are necessary to
         give effective protection to the interests referred to in that provision and, in particular, that the marketing of the products
         in question poses a real risk for public health (see Commission v Denmark, paragraph 46; and Commission v France, paragraph 53). 
         
         
         
         48
            
          A prohibition on the marketing of foodstuffs to which nutrients have been added must therefore be based on a detailed assessment
         of the risk alleged by the Member State invoking Article 36 of the Treaty (see Commission v Denmark, paragraph 47; and Commission v France, paragraph 54). 
         
         
         
         49
            
          A decision to prohibit the marketing of a fortified foodstuff, which indeed constitutes the most restrictive obstacle to trade
         in products lawfully manufactured and marketed in other Member States, can be adopted only if the real risk for public health
         alleged appears sufficiently established on the basis of the latest scientific data available at the date of the adoption
         of such decision. In such a context, the object of the risk assessment to be carried out by the Member State is to appraise
         the degree of probability of harmful effects on human health from the addition of certain nutrients to foodstuffs and the
         seriousness of those potential effects (see Commission v Denmark, paragraph 48; and Commission v France, paragraph 55). 
         
         
         
         50
            
          In assessing the risk in question, it is not only the particular effects of the marketing of an individual product containing
         a definite quantity of nutrients which are relevant. It could be appropriate to take into consideration the cumulative effect
         of the presence on the market of several sources, natural or artificial, of a particular nutrient and of the possible existence
         in the future of additional sources which can reasonably be foreseen (see Commission v Denmark, paragraph 50). 
         
         
         
         51
            
          In a number of cases, the assessment of those factors will demonstrate that there is much uncertainty, in science and in practice,
         in that regard. Such uncertainty, which is inseparable from the precautionary principle, affects the scope of the Member State’s
         discretion and thus also the manner in which the precautionary principle is applied. 
         
         
         
         52
            
          It must therefore be accepted that a Member State may, in accordance with the precautionary principle, take protective measures
         without having to wait until the existence and gravity of those risks become fully apparent (see, to that effect, National Farmers’ Union, paragraph 63). However, the risk assessment cannot be based on purely hypothetical considerations (see Monsanto Agricoltura Italia, paragraph 106; Commission v Denmark, paragraph 49; and Commission v France, paragraph 56).
         
         
         
         53
            
          A proper application of the precautionary principle requires, in the first place, the identification of the potentially negative
         consequences for health of the proposed addition of nutrients, and, secondly, a comprehensive assessment of the risk for health
         based on the most reliable scientific data available and the most recent results of international research (see Commission v Denmark, paragraph 51). 
         
         
         
         54
            
          Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency,
         inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists
         should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (see Commission v Denmark, paragraphs 52 and 53). 
         
         
         
         55
            
          In the present case, the competent Netherlands authorities appear to examine separately, first, the specific effects of marketing
         an individual foodstuff containing a given quantity of nutrients, which they assess as part of the first criterion, and secondly
         the cumulative effect of the presence on the market of several sources, natural or artificial, of a nutrient, which they assess
         as part of the second criterion, relating to a nutritional need in the Netherlands population. 
         
         
         
         56
            
          The Netherlands Government states that, for vitamin A (in the form of retinoids), vitamin D, folic acid, selenium, zinc and
         copper, the toxicological maximum, that is, the quantity above which the appearance of harmful effects may not be excluded,
         is not much higher than the recommended daily allowance, that is, the quantity which covers virtually all of the need for
         a given nutrient for all persons in good health in a particular population group, so that their addition to foodstuffs may
         be authorised only to a limited extent. For those ‘narrow safety margin’ nutrients, it is necessary to weigh the need to add
         them to foodstuffs against the risks that that entails and, where necessary and where justified by the risk assessment, apply
         restrictions to the marketing of products which do not meet a given nutritional objective.
         
         
         
         57
            
          However, even though it has been scientifically proven that the six nutrients at issue here carry a ‘narrow safety margin’,
         the recommended daily allowance of those nutrients is not the same as the toxicological maximum. In addition, as stated by
         the Advocate General in paragraph 42 of his Opinion, the slight difference between the recommended daily allowance and the
         quantity above which there is a health risk is not the same for each nutrient.
         
         
         
         58
            
          It follows that a foodstuff fortified with a given nutrient may not meet a nutritional need because the average food intake
         already provides the recommended daily allowance of that nutrient, although the marketing of that nutrient does not necessarily
         lead to intake over the toxicological maximum above which, according to current scientific knowledge, there is a real risk
         for public health.
         
         
         
         59
            
          In any event, the Netherlands Government has not produced any scientific studies showing that any intake over the recommended
         daily allowance of any of the six nutrients in question, regardless of by how much, entails a real risk for public health.
         
         
         
         60
            
          The Netherlands Government also submits that it is justified in refusing to allow the marketing of a fortified foodstuff which
         does not pursue any demonstrable nutritional objective, even when the ‘upper limit’ is not yet reached, in order to leave
         room for other products for which the nutritional need among certain groups among the population may be demonstrated.
         
         
         
         61
            
          In that connection, although the marketing of a fortified foodstuff intended for the entire population effectively reduces
         the difference between the quantity of nutrient present in the average food intake and the toxicological maximum, that in
         no way prevents the competent national authorities from subsequently authorising the marketing of other products fortified
         with the same nutrient intended only for groups in the population for whom the average food intake does not allow them to
         satisfy their need for that nutrient. Accordingly, the explanation given by the Netherlands Government cannot justify a practice
         of prohibiting a fortified foodstuff the consumption of which does not, even taking account of the overall food intake, attain
         the threshold above which there may be a real risk for public health.
         
         
         
         62
            
          Moreover, as rightly pointed out by the Commission, even after the national authorities have authorised the marketing of a
         foodstuff fortified with a given nutrient, they remain free to refuse a subsequent application for marketing authorisation
         on the basis of the situation brought about by the first authorisation (see, to that effect, the judgment of the EFTA Court
         of 5 April 2001 in Case E-3/00 EFTA Surveillance Authority v Norway [2000-2001] EFTA Court Report, p. 73, paragraphs 36 and 37).
         
         
         
         63
            
          In those circumstances, the systematic prohibition on the marketing of fortified foodstuffs, as it results from the administrative
         practice in the Netherlands, does not enable Community law to be observed in regard to the identification and assessment of
         a real risk for public health, which requires a detailed assessment, case by case, of the effects which the addition of the
         minerals and vitamins in question could entail (see, to that effect, Commission v Denmark, paragraph 56).
         
         
         
         64
            
          Moreover, as rightly observed by the Commission, the case-file does not show that, in the derogation application procedures,
         the Netherlands authorities consider whether the foodstuff fortified with a given nutrient might be a substitute, in food
         intake, for traditional foodstuffs for which the addition of that nutrient is mandatory, nor even whether they take such a
         substitutive effect into account, where appropriate.
         
         
         
         65
            
          Thus, the Netherlands Government acknowledges that, in general, cereals may be a substitution product for slices of bread.
         Until 1 December 1999, the Netherlands rules required fat spreads to be fortified with vitamin D. However, the case-file does
         not show that, in the course of the appraisal of the application for authorisation to market cereals fortified with vitamin
         D, submitted by the trader Kellogg’s, the Netherlands authorities took that fact into account when they checked whether the
         marketing of those cereals would lead to an increase in the quantity of vitamin D in the average food intake of cereal consumers
         in relation to the quantity judged to be acceptable, and even necessary, in the average food intake of consumers of spreads.
         
         
         
         
         66
            
          The search for a possible substitutive effect must, however, be part and parcel of the in-depth study required by the case-law
         of the Court. Taking such an effect into account, where it exists, may lead to the conclusion that the marketing of a new
         fortified foodstuff will not lead to an increase in the quantity of nutrient in the average food intake, so that a derogation
         may be granted. Conversely, not taking that effect into account might shape food habits in a certain manner without any justification
         based on public health.
         
         
         
         67
            
          Accordingly, the Court finds that the Netherlands authorities have not complied with the requirements of Community law, particularly
         the requirement of an in-depth assessment, case by case, of the possible effects on public health of marketing foodstuffs
         fortified with any of the six nutrients in question.
         
         
         
         68
            
          Even though the cumulative effect of the presence on the market of a number of sources, natural or artificial, of a given
         nutrient and, therefore, the existence of a real risk for public health, are also examined by the Netherlands authorities
         as part of the criterion of nutritional need, the case-file nevertheless shows that, in fact, a marketing authorisation for
         a fortified foodstuff is granted only if it is also established that it is necessary to enable the Netherlands population
         to cover its needs for vitamins or minerals (see the decision of the Netherlands Secretary for Welfare, Health and Culture
         taken in the ‘Punica’ case, cited in paragraph 35 of this judgment). This latter approach is not part of the assessment of
         risk for public health, however. 
         
         
         
         69
            
          Although the criterion of nutritional need of the population of a Member State can play a role in its detailed assessment
         of the risk which the addition of nutrients to foodstuffs may pose for public health, the absence of such a need cannot, by
         itself, justify a total prohibition, on the basis of Article 36 of the Treaty, of the marketing of foodstuffs lawfully manufactured
         and/or marketed in other Member States (see Commission v Denmark, paragraph 54; and Commission v France, paragraphs 59 and 60). 
         
         
         
         70
            
          It follows from all of the foregoing considerations that, by applying an administrative practice under which foodstuffs for
         everyday consumption fortified with vitamin A (in the form of retinoids), vitamin D, folic acid, selenium, copper or zinc
         which are lawfully produced or marketed in other Member States may be marketed in the Netherlands, when they are neither substitution
         products nor reconstituted foodstuffs within the meaning of Article 1(1)(c) and (d) of the TML Decree, only if that enrichment
         meets a nutritional need in the Netherlands population and, in addition, without ascertaining whether those fortified foodstuffs
         might be a substitute for foodstuffs already marketed for which the addition of those nutrients is mandatory, the Kingdom
         of the Netherlands has failed to fulfil its obligations under Article 30 of the Treaty. 
         
         
         Costs
         71
            
          Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been
         applied for in the successful party’s pleadings. Since the Commission has applied for costs and the Kingdom of the Netherlands
         has been unsuccessful, the latter must be ordered to pay the costs.
         
         
         
         
         
         
            
            
         
         
          On those grounds, the Court (Third Chamber) hereby:
         
            
            
             
               1.
                  Declares that, by applying an administrative practice under which foodstuffs for everyday consumption fortified with vitamin
                     A (in the form of retinoids), vitamin D, folic acid, selenium, copper or zinc which are lawfully produced or marketed in other
                     Member States may be marketed in the Netherlands, when they are neither substitution products nor reconstituted foodstuffs
                     within the meaning of Article 1(1)(c) and (d) of the Warenwetbesluit Toevoeging micro-voedingsstoffen aan levensmiddelen (Decree
                     implementing the Warenwet, on the addition of micronutrients to foodstuffs) of 24 May 1996 only if that enrichment meets a
                     nutritional need in the Netherlands population and, in addition, without ascertaining whether those fortified foodstuffs might
                     be a substitute for foodstuffs already marketed for which the addition of those nutrients is mandatory, the Kingdom of the
                     Netherlands has failed to fulfil its obligations under Article 30 of the EC Treaty (now, after amendment, Article 28 EC);
                  
               
            
            
            
             
               2.
                  Orders the Kingdom of the Netherlands to pay the costs.
               
            
             Signatures.
      
      
          1 –
            
            Language of the case: Dutch.