CELEX: 62013CC0137
Language: en
Date: 2014-05-08 00:00:00
Title: Opinion of Advocate General Sharpston delivered on 8 May 2014. # Herbaria Kräuterparadies GmbH v Freistaat Bayern. # Reference for a preliminary ruling: Bayerisches Verwaltungsgericht München - Germany. # Request for a preliminary ruling - Agriculture - Common agricultural policy - Organic production and labelling of organic products - Regulation (EC) No 889/2008 - Article 27(1)(f) - Use of certain products and certain substances in the processing of foodstuffs - Prohibition of the use of minerals, vitamins, amino acids and micronutrients where not legally required - Addition of ferrous gluconate and vitamins to an organic beverage - Use of minerals, vitamins, amino acids and micronutrients - Quantities required to allow sale as a food supplement, with a nutrition or health claim or as a foodstuff for a particular nutritional use. # Case C-137/13.

OPINION OF ADVOCATE GENERAL
      SHARPSTON
      delivered on 8 May 2014 (
            1
         )
      
         Case C‑137/13
      
      
         Herbaria Kräuterparadies GmbH
      
      
         v
      
      
         Freistaat Bayern
      
      
         (Request for a preliminary ruling from the Bayerisches Verwaltungsgericht München (Germany))
      
      ‛Agriculture — Labelling of organic products — Regulation (EC) No 889/2008 — Article 27(1)(f) — Use of products and substances in the processing of foodstuffs labelled as organic — Prohibition of the use of minerals and vitamins where not legally required — Addition of ferrous gluconate and vitamins to an organic fruit juice mixture — Quantities required to allow sale as a food supplement, with a nutrition or health claim or as a foodstuff for a particular nutritional use’
      
               1. 
            
            
               This is a request for a preliminary ruling from the Bayerisches Verwaltungsgericht München (Bavarian Administrative Court, Munich (Germany); ‘the Verwaltungsgericht’)
            
         
               2. 
            
            
               It concerns a product which contains mainly organically farmed ingredients, but also non-organic mineral and vitamin additives. May it be labelled and marketed as ‘organic’? In particular, are such additives ‘legally required’ if the product is marketed as a food supplement and/or as having health or nutritional benefits which cannot be achieved without them?
            
         
               3. 
            
            
               Before this Court, the (European) manufacturer of the product also claims that comparable products imported from the United States of America (‘US’) may be marketed in the European Union (‘EU’) bearing ‘organic’ labelling which complies with US rules equivalent, but not identical, to EU rules.
            
         
         Legislative background
      
      
         Food supplements and nutritional substances
      
      
               4.
            
            
               Recital 9 in the preamble to Directive 2002/46 (
                     2
                  ) states: ‘Only vitamins and minerals normally found in, and consumed as part of, the diet should be allowed to be present in food supplements although this does not mean that their presence therein is necessary. …’
            
         
               5.
            
            
               Recital 15 states: ‘Food supplements are purchased by consumers for supplementing intakes from the diet. In order to ensure that this aim is achieved, if vitamins and minerals are declared on the label of food supplements, they should be present in the product in a significant amount.’
            
         
               6.
            
            
               Article 2 of that directive defines (a) food supplements as ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form …’ and (b) nutrients as vitamins or minerals. Article 4(1), read in conjunction with Annexes I and II, lays down an exhaustive list of vitamins and minerals which may be used for the manufacture of food supplements.
            
         
               7.
            
            
               Article 5(3) provides: ‘To ensure that significant amounts of vitamins and minerals are present in food supplements, minimum amounts per daily portion of consumption as recommended by the manufacturer shall be set, as appropriate.’ Under Article 5(4), the minimum amounts of vitamins and minerals referred to in paragraph 3 are to be set by the Commission. However, no such amounts have in fact yet been set.
            
         
               8.
            
            
               Under Article 6(3)(a), the labelling must bear the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances.
            
         
         Nutrition and health claims
      
      
               9.
            
            
               Article 2(2)(1) of Regulation No 1924/2006 (
                     3
                  ) defines a ‘claim’ as ‘any message or representation, which is not mandatory under Community or national legislation, … which states, suggests or implies that a food has particular characteristics’.
            
         
               10.
            
            
               Article 3 provides:
               ‘Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market in the Community only if they comply with the provisions of this Regulation.
               … the use of nutrition and health claims shall not:
               
                        (a)
                     
                     
                        be false, ambiguous or misleading;
                     
                  ...’
            
         
               11.
            
            
               Article 5(1) provides, inter alia:
               ‘The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:
               
                        (a)
                     
                     
                        the presence … in a food or category of food of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific evidence;
                     
                  
                        (b)
                     
                     
                        the nutrient or other substance for which the claim is made:
                        
                                 (i)
                              
                              
                                 is contained in the final product in a significant quantity as defined in Community legislation or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific evidence;
                              
                           ...’
                     
                  
         
               12.
            
            
               Article 8(1) provides: ‘Nutrition claims shall only be permitted if they are listed in the Annex and are in conformity with the conditions set out in this Regulation.’ Article 13(1) also allows the use of, in particular, health claims describing or referring to the role of a nutrient or other substance in growth, development and the functions of the body which are based on generally accepted scientific evidence and well understood by the average consumer, and are included in a list to be drawn up, pursuant to Article 13(3), by the Commission.
            
         
               13.
            
            
               The Annex to Regulation No 1924/2006, under the heading ‘SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]’ states: ‘A claim that a food is a source of vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC …’ (
                     4
                  )
            
         
               14.
            
            
               The Annex to Regulation No 432/2012 (
                     5
                  ) contains a list of health claims which may be made on foods, as referred to in Article 13(3) of Regulation (EC) No 1924/2006. For iron, ‘Iron contributes to normal formation of red blood cells and haemoglobin’ is a claim that may be used, but only for food which is at least a source of iron as referred to in the claim.
            
         
         Foodstuffs for particular nutritional uses
      
      
               15.
            
            
               Article 1(2) of Directive 2009/39 (
                     6
                  ) defines foodstuffs for particular nutritional uses as ‘foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability’.
            
         
               16.
            
            
               Article 1(3) provides:
               ‘A particular nutritional use shall fulfil the particular nutritional requirements:
               
                        (a)
                     
                     
                        of certain categories of persons whose digestive processes or metabolism are disturbed; or
                     
                  
                        (b)
                     
                     
                        of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or
                     
                  
                        (c)
                     
                     
                        of infants or young children in good health.’
                     
                  
         
               17.
            
            
               Article 3(1) requires the nature or composition of foodstuffs for particular nutritional uses to be such that the products are appropriate for the particular nutritional use intended.
            
         
               18.
            
            
               Article 4(3) instructs the Commission to adopt a list of substances with specific nutritional purposes, including vitamins and mineral salts, intended to be added to foodstuffs for particular nutritional uses.
            
         
               19.
            
            
               That list was adopted in the Annex to Regulation No 953/2009, (
                     7
                  ) recital 5 in the preamble to which states: ‘Where the addition of a nutritional substance has been judged necessary, this has been stipulated by specific rules in the relevant specific directives together with the appropriate quantitative conditions, as the case may be.’
            
         
         Labelling of organic foodstuffs produced in the EU
      
      
               20.
            
            
               The preamble to Regulation No 834/2007 (
                     8
                  ) contains, inter alia, the following recitals:
               
                        ‘(20)
                     
                     
                        Processed food should be labelled as organic only where all or almost all the ingredients of agricultural origin are organic. However, special labelling provisions should be laid down for processed foods which include agricultural ingredients that cannot be obtained organically ...
                     
                  …
               
                        (22)
                     
                     
                        It is important to maintain consumer confidence in organic products. Exceptions from the requirements applicable to organic production should therefore be strictly limited to cases where the application of exceptional rules is deemed to be justified.
                     
                  ...’
            
         
               21.
            
            
               Article 3 of that regulation sets out the general objectives to be pursued by organic production, including, under (c), ‘producing a wide variety of foods and other agricultural products that respond to consumers’ demand for goods produced by the use of processes that do not harm the environment, human health, plant health or animal health and welfare’.
            
         
               22.
            
            
               Article 6 provides:
               ‘… the production of processed organic food shall be based on the following specific principles:
               
                        (a)
                     
                     
                        the production of organic food from organic agricultural ingredients, except where an ingredient is not available on the market in organic form;
                     
                  
                        (b)
                     
                     
                        the restriction of the use of food additives, of non-organic ingredients with mainly technological and sensory functions and of micronutrients and processing aids, so that they are used to a minimum extent and only in case of essential technological need or for particular nutritional purposes;
                     
                  
                        (c)
                     
                     
                        the exclusion of substances and processing methods that might be misleading regarding the true nature of the product;
                     
                  ...’
            
         
               23.
            
            
               Article 19 is entitled ‘General rules on the production of processed food’. Article 19(2) provides, in particular:
               ‘The following conditions shall apply to the composition of organic processed food:
               
                        (a)
                     
                     
                        the product shall be produced mainly from ingredients of agricultural origin; ...
                     
                  
                        (b)
                     
                     
                        only additives, processing aids, flavourings, water, salt, preparations of micro-organisms and enzymes, minerals, trace elements, vitamins, as well as amino acids and other micronutrients in foodstuffs for particular nutritional uses may be used, and only in so far as they have been authorised for use in organic production in accordance with Article 21;
                     
                  ...’
            
         
               24.
            
            
               Article 21 provides, in particular:
               ‘1.   The authorisation of products and substances for use in organic production and their inclusion in a restricted list of the products and substances referred to in Article 19(2)(b) … shall be subject to … the following criteria, which shall be evaluated as a whole:
               
                        (i)
                     
                     
                        alternatives authorised in accordance with this chapter are not available;
                     
                  
                        (ii)
                     
                     
                        without having recourse to them, it would be impossible to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of the Community legislation.
                     
                  In addition, the products and substances referred to in Article 19(2)(b) are to be found in nature and may have undergone only mechanical, physical, biological, enzymatic or microbial processes, except where such products and substances from such sources are not available in sufficient quantities or qualities on the market.
               2.   The Commission shall … decide on the authorisation of the products and substances and their inclusion in the restricted list referred to in paragraph 1 of this Article and lay down specific conditions and limits for their use, and, if necessary, on the withdrawal of products.
               …’
            
         
               25.
            
            
               Article 23 (‘Use of terms referring to organic production’) provides, inter alia:
               ‘1.   For the purposes of this Regulation a product shall be regarded as bearing terms referring to the organic production method where, in the labelling, advertising material or commercial documents, such a product, its ingredients or feed materials are described in terms suggesting to the purchaser that the product, its ingredients or feed materials have been obtained in accordance with the rules laid down in this Regulation. In particular, the terms listed in the Annex, [ (
                     9
                  ) ] their derivatives or diminutives, such as “bio” and “eco”, alone or combined, may be used throughout the Community and in any Community language for the labelling and advertising of products which satisfy the requirements set out under or pursuant to this Regulation.
               …
               2.   The terms referred to in paragraph 1 shall not be used anywhere in the Community and in any Community language for the labelling, advertising and commercial documents of a product which does not satisfy the requirements set out under this Regulation, unless they are not applied to agricultural products in food or feed or clearly have no connection with organic production.
               …
               4.   As regards processed food, the terms referred to in paragraph 1 may be used:
               
                        (a)
                     
                     
                        in the sales description, provided that:
                        
                                 (i)
                              
                              
                                 the processed food complies with Article 19;
                              
                           
                                 (ii)
                              
                              
                                 at least 95% by weight, of its ingredients of agricultural origin are organic;
                              
                           
                  ...’
            
         
               26.
            
            
               Article 27 of Regulation No 889/2008 (
                     10
                  ) is entitled ‘Use of certain products and substances in processing of food’. Article 27(1) provides, inter alia:
               ‘For the purposes of Article 19(2)(b) of Regulation (EC) No 834/2007, only the following substances can be used in the processing of organic food ...:
               ...
               
                        (f)
                     
                     
                        minerals (trace elements included), vitamins, aminoacids, and micronutrients, only authorised as far [as] their use is legally required in the foodstuffs in which they are incorporated.’
                     
                  
         
         Labelling of imports of organic products from the USA
      
      
               27.
            
            
               Recital 33 in the preamble to Regulation No 834/2007 states:
               ‘Organic products imported into the European Community should be allowed to be placed on the Community market as organic, where they have been produced in accordance with production rules and subject to control arrangements that are in compliance with or equivalent to those laid down in Community legislation. In addition, the products imported under an equivalent system should be covered by a certificate issued by the competent authority, or recognised control authority or body of the third country concerned.’
            
         
               28.
            
            
               Those aims are given effect, for compliant products, by Article 32 of that regulation and, for products providing equivalent guarantees, by Article 33. Article 33(1) allows the latter to be placed on the market in the EU provided that (a) they are produced in accordance with equivalent production rules, (b) the operators have been subject to control measures of equivalent effectiveness and (c) have submitted their activities to a recognised control system, and (d) the products are covered by a control certificate issued by a competent body. Article 33(2) authorises the Commission to draw up a list of third countries having equivalent production rules and control measures of equivalent effectiveness.
            
         
               29.
            
            
               Title III of Regulation No 1235/2008 (
                     11
                  ) is entitled ‘Import of products providing equivalent guarantees’. Article 7 within that title concerns the compilation and content of the list of recognised third countries, which is set out in Annex III, while Article 10 concerns the compilation and content of the list of recognised control bodies and control authorities for the purpose of equivalence, set out in Annex IV.
            
         
               30.
            
            
               Those annexes have been amended in particular by Regulation No 126/2012 (
                     12
                  ) which — with effect from 1 June 2012 to 30 June 2015 — added the US to the list of recognised third countries for, inter alia, processed agricultural products for use as food and listed the recognised control bodies in that country.
            
         
               31.
            
            
               Recital 4 in the preamble to Regulation No 126/2012 states:
               ‘Certain agricultural products imported from the [US] are currently marketed in the [EU] pursuant to the transitional rules provided for in Article 19 of [Regulation No 1235/2008]. The [US] submitted a request to the Commission to be included in the list provided for in Article 7 of Regulation (EC) No 1235/2008. It submitted the information required pursuant to Articles 7 and 8 of that Regulation. The examination of that information and subsequent discussions with the US authorities have led to the conclusion that in that country the rules governing the production and controls of organic agricultural products are equivalent to those laid down in Regulation (EC) No 834/2007. The Commission has carried out a satisfactory on-the-spot check of the rules of production and the control measures actually applied in the [US], as provided for in Article 33(2) of Regulation (EC) No 834/2007. Consequently, the [US] should be included in the list set out in Annex III to Regulation (EC) No 1235/2008.’
            
         
         Facts, procedure and questions referred
      
      
               32.
            
            
               Herbaria Kräuterparadies GmbH (‘Herbaria’) manufactures ‘Herbaria Blutquick — Eisen + Vitamine’ (Herbaria Blutquick — Iron + Vitamins, hereinafter ‘Blutquick’), a fruit juice mixture with herbal extracts. Although consisting mainly of ingredients of organic agricultural origin within the meaning of Article 19(2)(a) of Regulation No 834/2007, Blutquick contains non-organic vitamins and ferrous gluconate. It is advertised and marketed as a food supplement containing iron and vitamins, and its label bears a reference to organic production within the meaning of Article 23 of Regulation No 834/2007, together with the claim: ‘Iron supports the normal formation of red blood cells and haemoglobin’. The recommended daily intake covers 20% of the RDA. Blutquick is also recommended as beneficial to children’s natural intellectual development if taken during pregnancy and breastfeeding, as combating exhaustion and as beneficial to general well-being.
            
         
               33.
            
            
               In December 2011, the competent Bavarian authorities ordered Herbaria to remove the reference to organic farming in the labelling, advertising and marketing of Blutquick, on the ground that it infringed Article 23(4)(a)(i) of Regulation No 834/2007 in conjunction with Article 19(2)(b) of Regulation No 834/2007 and Article 27(1)(f) of Regulation No 889/2008. Their reasons were as follows. Minerals and vitamins could be added only to the extent that their use was legally required in the foodstuffs in which they were incorporated. There was no such legal requirement for Blutquick. It was in particular not a product covered by the national dietetic foods regulation (the Diätverordnung). The fact that Regulation No 1924/2006 subjected ‘nutrition and health claims’ to detailed requirements did not mean that the use of vitamins and minerals was legally required in the manufacture of foodstuffs if they were not covered by the Diätverordnung. Even if Blutquick was authorised under Regulation No 1924/2006, it could not be labelled, advertised or marketed bearing the reference to organic production regulated by Article 23 of Regulation No 834/2007, since Regulation No 1924/2006 does not require foodstuffs and food additives to contain vitamins or to be enriched with ferrous gluconate.
            
         
               34.
            
            
               Herbaria challenged that decision, arguing in particular that Article 27(1)(f) of Regulation No 889/2008 was intended to permit the addition of minerals and vitamins if and in so far as other EU or national provisions required a specific vitamin or mineral content where a foodstuff could not fulfil its stated purpose without such content. The point of reference was the particular foodstuff and its specific intended use. Provisions concerning food supplements or health and nutrition claims, in particular in Regulation No 1924/2006, required minerals and vitamins to be added to foodstuffs labelled as having a specific nutritional function. The prohibition of misleading claims required the manufacturer’s recommended daily intake to cover 15% of the maximum amount suggested by the authorities as the guaranteed amount. (
                     13
                  ) The stated purpose of a food supplement was the basis for the legal obligation to achieve the corresponding minimum values. If those values could be achieved only by addition of substances, the addition was legally required. In addition, Regulation No 432/2012 laid down legal requirements for daily intakes and therefore required substances to be added to an organic foodstuff. The addition of ferrous gluconate and vitamins to Blutquick was essential in order to achieve the nutritional values required for the stated nutritional purpose. That could not be done using ingredients derived from organic products. The additions were limited to what was necessary.
            
         
               35.
            
            
               The authorities responded that there was no legal requirement to add vitamins or ferrous gluconate. Regulation No 1924/2006 merely allowed the addition of those substances, but did not require it. A contrary interpretation would infringe Article 6(b) of Regulation No 834/2007, according to which food additives in organic farming are to be kept to a minimum.
            
         
               36.
            
            
               In those circumstances, the Verwaltungsgericht seeks a preliminary ruling on the following questions:
               
                        ‘(1)
                     
                     
                        Is Article 27(1)(f) of Regulation (EC) No 889/2008 to be interpreted as meaning that the use of the substances referred to is legally required only when a provision of EU law or a provision of national law compatible with EU law directly requires, in respect of the foodstuff in which the substances referred to are to be incorporated, that the substances referred to be added or at least lays down a minimum content in respect of the substances referred to, which should be incorporated?
                     
                  
                        (2)
                     
                     
                        If the first question is answered in the negative: Is Article 27(1)(f) of Regulation (EC) No 889/2008 to be understood as meaning that the use of the substances referred to is also legally required where the marketing of a foodstuff as a food supplement or bearing health claims would, without the addition of at least one of the substances referred to, tend to mislead the consumer because the foodstuff cannot, in the absence of one of the substances referred to in sufficient strength, fulfil its stated purpose as a foodstuff or its stated purpose as expressed by the health claim?
                     
                  
                        (3)
                     
                     
                        If the first question is answered in the negative: Is Article 27(1)(f) of Regulation (EC) No 889/2008 to be understood as meaning that the use of the substances referred to is also legally required where a specific health claim may be used only for foodstuffs which contain a certain, so-called significant, amount of at least one of the substances referred to?’
                     
                  
         
               37.
            
            
               Written observations have been submitted by the parties to the main proceedings, by the Czech, French and Spanish Governments and by the European Commission, who also, with the exception of the Czech and Spanish Governments, presented oral submissions at the hearing on 13 February 2014.
            
         
               38.
            
            
               Essentially, all those submitting observations, apart from Herbaria, consider that the first question should be answered in the affirmative, and that there is no EU legal requirement on which Herbaria can rely. Herbaria takes the contrary view but raises also the issue of imports of US food supplements which, it claims, can be labelled as organic even though they contain added iron and vitamins. That issue, not having been raised by the referring court, was not addressed in any of the other observations but was debated at the hearing.
            
         
         Assessment
      
      
         Interpretation of the legislation
      
      
               39.
            
            
               The three questions referred may be reformulated together as asking whether the words ‘legally required in the foodstuffs in which they are incorporated’ in Article 27(1)(f) of Regulation No 889/2008 refer (a) only to a direct legal requirement for one or more of the substances listed to be present in a foodstuff if it is to be marketed at all, regardless of any statements as to its qualities or intended use, or (b) also to a situation in which the foodstuff is marketed as a food supplement, with a nutrition or health claim or for a particular nutritional use but may not be so marketed unless it contains a specified amount of one or more of those substances.
            
         
               40.
            
            
               Article 23(2) of Regulation No 834/2007 precludes the use of a reference to organic production for any product which does not satisfy the requirements set out in that regulation. Article 23(4) makes it clear that such a reference is permitted with regard to processed food (and a fruit juice mixture with herbal extracts is necessarily a processed food) only if that food complies with Article 19. Article 19(2)(b) allows the addition of, inter alia, minerals and vitamins only in so far as they have been authorised for use in organic production in accordance with Article 21. Article 21 lays down general criteria for authorising the use of such substances and delegates to the Commission the task of drawing up a restricted list within the framework of those criteria. The general criteria are that no authorised alternatives must be available and that the substance must be necessary to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of EU legislation.
            
         
               41.
            
            
               On that basis, the Commission has drawn up, in Article 27(1) of Regulation No 889/2008, the restricted list of substances which may be used in the processing of food which is marketed as organic. Under Article 27(1)(f), minerals and vitamins are authorised only in so far as their use is legally required.
            
         
               42.
            
            
               The language of those provisions (
                     14
                  ) makes it clear that they are intended to be interpreted restrictively — as is confirmed by recital 22 in the preamble to Regulation No 834/2007, which states that, in order to maintain consumer confidence, exceptions to the requirements applicable to organic production should be strictly limited to justified cases.
            
         
               43.
            
            
               I thus have no hesitation in concluding that the use of ‘legally required’ in Article 27(1)(f) of Regulation No 889/2008 should be interpreted strictly as concerning only a direct legal requirement that the substance should be used in the processing of the food in question.
            
         
               44.
            
            
               It is not argued that there is any legal requirement, under EU law or any national law compatible therewith, for a fruit juice mixture with herbal extracts sold simply as a foodstuff, whether organic or not, to contain any specified quantity or iron or of any particular vitamin.
            
         
               45.
            
            
               None the less, in some circumstances, it might be considered that there is a legal requirement for such a product to contain certain minerals or vitamins in specified amounts if it is to be sold as a food supplement, with a nutrition or health claim or as a foodstuff for a particular nutritional use and the presence of those amounts is necessary in order for it marketed in such a way. However, I would not agree with such an analysis.
            
         
               46.
            
            
               As regards food supplements, the Commission points out that, although minimum amounts of vitamins and minerals in food supplements may be set pursuant to Article 5(3) and (4) of Directive 2002/46, no such amounts have in fact yet been set. Nor — although this is a matter which only the Verwaltungsgericht can determine — do any such amounts appear to have been set in applicable German legislation. (
                     15
                  ) Moreover, even if minimum amounts had been set, that would not impose a requirement on producers to include any particular mineral or vitamin in their products; rather, it would preclude them from marketing those products as food supplements containing the substance or substances in question unless the minimum amount or amounts were present.
            
         
               47.
            
            
               As regards nutrition and health claims, it is clear from the provisions of Regulation No 1924/2006 and Regulation No 432/2012 set out at points 9 to 14 above that the claims made for Blutquick are such that they may be made only if iron and vitamins are present in significant amounts. However, as the Commission again points out, a claim within the meaning of Regulation No 1924/2006 is specifically one which is not mandatory under EU or national legislation. Again, therefore, the provisions in question do not impose any legal requirement as to the content of the foodstuffs concerned; rather, they specify the conditions in which nutrition or health claims may be made.
            
         
               48.
            
            
               Finally, as regards foodstuffs for particular nutritional uses, it is first of all by no means evident from the case-file that Blutquick falls within the definition of such foodstuffs in Article 1(2) and (3) of Directive 2009/39, although it does appear to be aimed at, inter alia, breastfeeding mothers and persons suffering from exhaustion, who might be considered to be ‘in a special physiological condition and … therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs’. But in any event, as the French Government points out, nutritional substances are to be added only when ’stipulated by specific rules in the relevant specific directives together with the appropriate quantitative conditions, as the case may be’. (
                     16
                  ) And, yet again, there is no obligation to market, for example, a fruit juice mixture as a foodstuff for a particular nutritional use, but only a prohibition on marketing it as such if it does not meet the requirements of Directive 2009/39 and Regulation No 953/2009.
            
         
               49.
            
            
               In brief, all the instances cited in the request for a preliminary ruling, or by Herbaria, in which the addition of minerals and/or vitamins might be considered to be ‘legally required’ are in fact cases in which the manufacturer is precluded from marketing the product as a food supplement, with nutrition or health claims or as a foodstuff for a particular nutritional use unless a certain mineral or vitamin content is present. Since there is no legal requirement to market any product in those terms, it would require an unacceptably broad interpretation of Article 27(1)(f) of Regulation No 889/2008 to include such situations within its scope and to authorise on that basis the use of minerals and/or vitamins in the processing of foodstuffs to be marketed as organic.
            
         
               50.
            
            
               As the legislation stands, (
                     17
                  ) that appears to me to be the only possible coherent interpretation.
            
         
               51.
            
            
               I acknowledge that, in the context of the Agreement on Technical Barriers to Trade, (
                     18
                  ) the WTO Appellate Body has considered that a requirement to meet certain conditions in order to label a tuna product as ‘dolphin-safe’ (a situation not unlike that in the present case) is mandatory for the purposes of Annex 1.1 to that agreement even if the product could be marketed without such labelling. (
                     19
                  )
            
         
               52.
            
            
               However, the circumstances of the present case are more complex than those examined by the Appellate Body. It is not, here, simply a matter of compliance with particular conditions in order to use a particular statement on the labelling. It is, rather, a matter of reconciling two or more sets of requirements, not all of which can necessarily be met simultaneously, in order to use a combination of statements on the labelling.
            
         
               53.
            
            
               In EU law, certain conditions must be complied with in order for a product to be marketed as organic. Other conditions must be complied with in order for it to be marketed as a food supplement, with nutrition or health claims or as a foodstuff for a particular nutritional use. In order for it to be marketed both as organic and as a food supplement, with nutrition or health claims or as a foodstuff for a particular nutritional use, all the relevant conditions must be complied with. But in no case is there any legal requirement for a product to be marketed in any of those ways. Where the relevant conditions for marketing in a combination of ways cannot all be met simultaneously for the same product, it is for the producer to choose how to market the product and thus to ascertain which conditions must be complied with. As the French Government points out, a contrary approach would allow producers to market as organic products which contained unauthorised non-organic substances simply by choosing to make other claims, in addition to that of organic production, which could not be made without the addition of those substances.
            
         
               54.
            
            
               Herbaria none the less submits that the aim set out in Article 3(c) of Regulation No 834/2007, of producing a ‘wide variety’ of organic foods and products that respond to consumers’ demands, means that it must be possible to market organic products in all categories of foodstuff which meet those demands, including food supplements, dietary products and ordinary foodstuffs bearing nutrition or health claims.
            
         
               55.
            
            
               That argument does not convince me. The aim in question does of course include the marketing of organic products in such categories. It does not however include the marketing of products in those categories as organic when they do not meet the conditions for them to be marketed as organic.
            
         
               56.
            
            
               I am therefore of the view that the words ‘legally required in the foodstuffs in which they are incorporated’ in Article 27(1)(f) of Regulation No 889/2008 refer only to a direct legal requirement for one or more of the substances listed to be present in a foodstuff if it is to be marketed at all. They do not extend to a situation in which the foodstuff is marketed as a food supplement, with a nutrition or health claim or as a foodstuff for a particular nutritional use but may not be so marketed unless it contains a particular amount of one or more of those substances.
            
         
         Difference of treatment compared with imports from the US
      
      
               57.
            
            
               In its written observations to the Court, Herbaria submitted that, following the entry into force of Regulation No 126/2012 (which implemented an exchange of letters between the Commission and the US Department of Agriculture), foodstuffs produced in the US could be marketed as organic in the EU even if they contained non-organic nutrient vitamins and minerals, because such labelling was permitted in the US by §205.605 of Title 7 (Agriculture) of the Electronic Code of Federal Regulations. (
                     20
                  ) It cited a US product (Organic Life Vitamins), claimed to be comparable to Blutquick, as being marketed in the EU while containing non-organic vitamins and minerals. If Blutquick could not be similarly marketed, Herbaria’s right to equal treatment would be infringed.
            
         
               58.
            
            
               The oral submissions at the hearing were, at the Court’s request, devoted essentially to that issue.
            
         
               59.
            
            
               The issue is, potentially, of immense importance. It prefigures, in a rather more limited context, one of the types of issue likely to come to the fore in relation to the Transatlantic Trade and Investment Partnership (‘TTIP’) currently being negotiated between the Commission on behalf of the EU and the US Trade Representative on behalf of the US. (
                     21
                  ) It is an issue of ‘mutual recognition’ which raises questions of equality of treatment and, possibly, of reverse discrimination. If the EU must admit the import and subsequent sale, as organic, of foodstuffs which are not compliant with EU rules but merely provide equivalent guarantees, one may query whether it should not also be possible to market, as organic, foodstuffs produced in the EU which would meet the requirements of the rules which provide those equivalent guarantees. With regard to the TTIP, concerns have been voiced that, inter alia, there would be a de facto assimilation of vast swathes of regulatory measures and a consequent loss of regulatory autonomy.
            
         
               60.
            
            
               There are, however, in my view, cogent reasons why the Court should not address these matters in the context of the present proceedings.
            
         
               61.
            
            
               First and foremost, the Verwaltungsgericht has not sought any guidance on this issue — even though, according to the statement of counsel for Herbaria at the hearing, it was an issue which had been raised and debated in the national proceedings. The Court has consistently held that it is solely for the national court before which the dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. (
                     22
                  ) In that context, it must in my view also be, at least primarily, for the national court to determine that a question of EU law raised before it does not have to be decided in order to enable it to deliver judgment, and therefore, in the interests of procedural efficiency, should not be submitted to the Court. The preliminary ruling procedure has consistently been held to be a dialogue between one court and another, the initiation of which depends entirely on the national court’s assessment as to whether a request is appropriate and necessary. (
                     23
                  )
            
         
               62.
            
            
               Moreover, the fact that the Verwaltungsgericht has made no reference to the issue raised by Herbaria inevitably means that, with regard to that issue, its request for a preliminary ruling does not contain in full the elements required by Article 94 of the Court’s Rules of Procedure. In particular, there is no indication of any factual findings or assumptions regarding the comparability of Organic Life Vitamins to Blutquick, the former’s actual sale in the EU pursuant to the procedures laid down in Article 33 of Regulation No 834/2007 or the latter’s possible conformity with the US regulations had it been produced in the US; nor of course is there any indication of the reasons why a ruling on the interpretation of the rules regarding the labelling and marketing of organic foodstuffs from the US might be necessary.
            
         
               63.
            
            
               In so saying, I intend no criticism of the Verwaltungsgericht. On the contrary, that court has clearly taken an informed decision not to refer a question on that point and thus, quite rightly, to refrain from providing reasoning and factual details relating to it. Consequently, if the Court were to address the issue, it would have to do so in a void, knowing neither the reasons which prompted the Verwaltungsgericht not to seek guidance on that point nor the factual and procedural basis on which those reasons might be called into question. The Court would be exceeding the limits of the function entrusted to it if it decided to rule on a hypothetical problem without having before it the necessary factual or legal material. (
                     24
                  ) To answer a question raised by a party to the main proceedings without the consent of the referring court would seem to me to be exceeding even further the limits of that function.
            
         
               64.
            
            
               In addition, to address a question not raised in the request for a preliminary ruling — and one which is not even a natural or logical extrapolation from the issues set out in that document — but only in the observations of a party to the main proceedings would be to deprive the Member States in part of the rights they derive from Article 23 of the Statute of the Court of Justice, to be informed of the subject-matter of questions referred to the Court and to submit written observations on those questions. It is true that a Member State may request to make oral submissions at the hearing in response to points raised in the written observations. However, on the one hand, it may not have received those observations in its own official language, whereas the request for a preliminary ruling is always translated into, or at least summarised in, all the official languages of the EU, and, on the other hand, only a limited time is available at hearings and it may well not be possible to make such thorough and useful submissions as would have been the case in writing.
            
         
               65.
            
            
               Secondly, as the Commission pointed out at the hearing, the main proceedings concern a challenge to a decision taken by the Bavarian authorities in December 2011, whose validity should, presumably, therefore be assessed in accordance with the law in force at that time. In accordance with Article 3 thereof, Regulation No 126/2012, on which Herbaria bases its allegations, applied only from 1 June 2012. It thus appears that, at what seems to be the material time, there cannot have been any foodstuffs from the US containing non-organic vitamins and minerals, authorised for marketing as organic in the EU, on which Herbaria might have based a claim of unequal treatment.
            
         
               66.
            
            
               In those circumstances, I would recommend that the Court should not attempt to address the supplementary issue raised by Herbaria in the context of the present proceedings. If the Court should none the less see fit to do so, I consider that it should first request clarification from the Verwaltungsgericht pursuant to Article 101 of the Rules of Procedure and thereafter, if appropriate, reopen the oral procedure pursuant to Article 83 of those rules in order to enable any interested Member States to submit observations in the light of that clarification.
            
         
         Conclusion
      
      
               67.
            
            
               In the light of all the foregoing considerations, I am of the opinion that the Court should answer the request for a preliminary ruling to the following effect:
               Article 27(1)(f) of Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 is to be interpreted as meaning that the use of the substances referred to is legally required only when a provision of EU law or a provision of national law compatible with EU law directly requires, in respect of the foodstuff in which the substances referred to are to be incorporated, that such substances must be added, or at least lays down a minimum content thereof, before that foodstuff may be placed on the market.
               There is no such requirement where the marketing of a foodstuff as a food supplement, with a nutrition or health claim or as a foodstuff for a particular nutritional use would, without the addition of one or more of the substances referred to, tend to mislead the consumer because the foodstuff cannot, in the absence of such substance or substances in sufficient strength, fulfil its stated purpose as a foodstuff or its stated purpose as expressed by the nutrition or health claim. Nor is there such a requirement where a specific nutrition or health claim may be used only for foodstuffs which contain a ‘significant’ amount of the substance or substances referred to.
            
         (
            1
         )	Original language: English.
      (
            2
         )	Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51), as amended.
      (
            3
         )	Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9).
      (
            4
         )	Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs (OJ 1990 L 276, p. 40). Annex I states : ‘As a rule, 15% of the recommended allowance specified in this Annex supplied by 100 g or 100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount.’ A recommended daily allowance (‘RDA’) is set for a number of substances, including iron and the various vitamins claimed to be contained in the product in issue in the main proceedings.
      (
            5
         )	Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ 2012 L 136, p. 1).
      (
            6
         )	Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (recast) (OJ 2009 L 124, p. 21).
      (
            7
         )	Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (OJ 2009 L 269, p. 9).
      (
            8
         )	Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ 2007 L 189, p. 1).
      (
            9
         )	The Annex lists, for each of (now) 25 languages in use in the EU (the 24 official languages plus Luxembourgish), either one or two terms, almost all of which mean ‘biological’, ‘ecological’ or ‘organic’ (the exceptions are Estonian, in which a word apparently meaning ‘mild’ can be used, and Finnish, in which the meaning of the term given appears to be closer to ‘natural’).
      (
            10
         )	Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 (OJ 2008 L 250, p. 1).
      (
            11
         )	Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (OJ 2008 L 334, p. 25).
      (
            12
         )	Commission Implementing Regulation (EU) No 126/2012 of 14 February 2012 amending Regulation (EC) No 889/2008 as regards documentary evidence and amending Regulation (EC) No 1235/2008 as regards the arrangements for imports of organic products from the United States of America (OJ 2012 L 41, p. 5).
      (
            13
         )	This appears to refer to a national document entitled ‘Toxikologische und ernährungsphysiologische Aspekte der Verwendung von Mineralstoffen und Vitaminen in Lebensmitteln’ (Toxicological, nutritional and physiological aspects of the use of minerals and vitamins in foodstuffs), published in 2002 or 2004 by the German Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Consumer Health Protection and Veterinary Medicine), which makes certain recommendations for future legislation. See also footnote 4 above.
      (
            14
         )	See also Article 6 of Regulation No 834/2007, cited in point 22 above, which uses terms such as ‘restriction’, ‘to a minimum extent’, ‘only’, ‘essential’ and ‘exclusion’.
      (
            15
         )	The Verwaltungsgericht states that Blutquick is not a product covered by the Diätverordnung (see point 33 above). A document also mentioned in the order for reference (see footnote 13 above) proposes that, in order to prevent consumers from being misled, the minimum mineral content of food supplements should be such that 15% of the respective recommended maximum amount is attained by consumption of the intake stated by the manufacturer, but there is no indication that that proposal has been acted upon.
      (
            16
         )	See point 19 above.
      (
            17
         )	I shall not consider the question whether it should be possible for a product to be marketed with a reference to organic production in the circumstances of the main proceedings; that is a matter for the legislature alone.
      (
            18
         )	Annex 1A to the Uruguay Round of Multilateral Trade Negotiations, OJ 1994 L 336, p. 86 (the ‘TBT Agreement’).
      (
            19
         )	Appellate Body Report, United States — Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, WT/DS381/AB/R, adopted 13 June 2012, in particular at paragraph 196.
      (
            20
         )	http://www.ecfr.gov.
      (
            21
         )	See http://trade.ec.europa.eu/doclib/docs/2013/july/tradoc_151605.pdf for a brief summary. It may also be noted that Article 2.7 of the TBT Agreement (cited in footnote 18) requires Members to ‘give positive consideration to accepting as equivalent technical regulations of other Members, even if these regulations differ from their own, provided they are satisfied that these regulations adequately fulfil the objectives of their own regulations’.
      (
            22
         )	See, for a recent example, Nordecon and Ramboll Eesti (C‑561/12, EU:C:2013:793), paragraph 29.
      (
            23
         )	See, for a recent example, Križan and Others (C‑416/10, EU:C:2013:8), paragraph 66.
      (
            24
         )	See, for a recent example of the consistent case-law, the order in Società cooperativa Madonna dei miracoli (C‑82/13, EU:C:2013:655), paragraphs 11 and 12 and case-law cited.