Judgment — ECLI:EU:C:2011:541
Date: 2011-09-06
Language of the case: German
Court formation: Grand Chamber
Subject matter: Agriculture and Fisheries;Foodstuffs;Consumer protection;Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Germany

summary, as long as a given material, even in inactive state, still contains genetic information (DNA or RNA) that is capable of being incorporated by other entities, it should be regarded as an ‘organism’ within the meaning of that provision. 84. I do not agree with that argument for the following reasons. 85. I would point out, first of all, that the content of the Protocol and of the preparatory and explanatory documents rather substantiates the view that the reference to both replication and to the transfer of genetic material was meant to cover the various ways in which a biologically active entity transmits its genetic material. Given the similarity between the definitions contained in Article 3(h) of the Protocol and in Article 2(1) of Directive 2001/18, I doubt that the reference to the transfer of genetic material could have any broader significance under the latter provision, so as to also include the possibility of the horizontal transfer of genetic material by biologically dead entities. 86. Next, once a biological entity has lost its vital functions, it can no longer actively participate in the transfer of genetic material. It ceases to play any role in its transfer. If its genetic material is released, if it is received by bacteria, that amounts to a purely passive transmission of the genetic material, which is entirely dependent on the environment in which it happens to be. In such a scenario, the biological entity cannot, I consider, be regarded as still ‘capable’ of transferring genetic material. In other words, the simple presence of DNA in biological material which no longer possess any vital functions and the possible incorporation of that DNA by other organisms is not the same thing, to my mind, as a biological organism’s ability to transfer genetic material within the meaning of Article 2(1) of Directive 2001/18. 87. Furthermore, the line of argument which Mr Bablok and Others develop, and which places emphasis on the continued existence, under certain conditions, of genetic material after the death of a biological entity, tends to treat the organism and its genetic material as one and the same thing, that is to say, in essence, its DNA, since that will always be amenable to incorporation by another organism, so long as it is not destroyed. The two must not be confused. The explanation given in the handbook for the implementation of Directive 90/220 prepared by the Commission (26) makes that clear: ‘The definition of “organism” covers: micro-organisms, including viruses and viroids; plants and animals; including ova, seeds, pollen, cell cultures and tissue cultures from plants and animals. This definition does not cover naked r DNA and naked r-plasmids. ’ (27) (28) 88. I sympathise with the concern of Mr Bablok and Others, which is to ensure that, with a broader concept of organism, the risks associated with the horizontal transfer of genetic material will always undergo assessment. That legitimate concern, however, is not sufficient to bring within the definition of organism all biological entities, living or dead, belonging to a species capable of replication or of transferring genetic material. 89. Indeed, if the Community legislature meant, as I think it did, to restrict the meaning of ‘organism’ under Article 2(1) of Directive 2001/18 to biologically active entities, that does not mean that, when granting authorisation for the release of a GMO, there is no assessment of the risks arising from the horizontal transfer of the genetic material belonging to that organism, either while it is alive or after its death. Proof of that is Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC (29) (which itself address ‘Principles for the environmental risk assessment’). Among the characteristics which may have adverse effects, the Commission expressly identifies the transfer of genetic material, both vertical and horizontal. (30) That being so, the interpretation which I propose the Court should give to Article 2(1) of Directive 2001/18 undermines neither the precautionary principle nor the objective of protecting the environment and health. 90. It follows from all of the foregoing that pollen from MON 810 maize that is no longer viable, and which is thus no longer able to fulfil its function in the replication of that vegetable variety, cannot, in my opinion, be regarded as an ‘organism’ within the meaning of Article 2(1) of Directive 2001/18 and Article 2.4 of Regulation No 1829/2003. It follows that such pollen does not constitute a GMO within the meaning of Article 2(2) of that directive (31) or Article 2.5 of that regulation. A situation such as the one which preoccupies the referring court, namely the presence in honey or food supplements of non-viable pollen from a genetically modified plant, is not therefore a case of a ‘GMO for food use’ within the meaning of Article 3(1)(a) of Regulation No 1829/2003, or of a ‘food containing or consisting of GMOs’ within the meaning of Article 3(1)(b) of that regulation. (32) 91. In reaching that conclusion I adopt the same premiss as was suggested by the referring court, namely that pollen present in honey or used as a food supplement is no longer a living biological entity but is, by contrast, inanimate matter, different, for example, from a seed, which might still be able to germinate, even after incorporation within the food cycle. In the ultimate analysis, it is of course for the referring court to establish, on the basis of such scientific studies as may be presented to it, whether the pollen used as mentioned above is no longer a living biological entity. 92. As we shall now go on to see, the answer which I suggest the Court give to the first question does not mean that the presence in food of pollen from a genetically modified plant is a matter which falls outside the scope of Regulation No 1829/2003. Indeed, it is by way of the notion of food produced from a GMO that this type of situation may be caught by the regulation and that an assessment of the risks arising from the horizontal transfer of genetic material for that category of food may be carried out. (33) B – Consideration of the second question 93. The second question referred by the referring court falls into two parts. First, that court seeks a ruling from this Court, in essence, on whether Article 2.10 of Regulation No 1829/2003 is to be interpreted as meaning that it is sufficient, in order for food to be considered as being ‘produced from GMOs’, that it contain material from genetically modified plants which previously possessed a specific and individual capacity to reproduce. If that question is answered in the affirmative, the referring court then asks this Court to rule on whether the meaning of food ‘produced from GMOs’ requires that the GMO material is incorporated intentionally into the food or whether the expression also covers the involuntary contamination of food with GMO material. 94. As is clear from recital 3 in the preamble thereto, Regulation No 1829/2003 is founded on the fundamental idea that, in order to protect human and animal health, genetically modified food and feed must undergo a safety assessment through a Community procedure before being placed on the market within the Community. 95. By ‘genetically modified food’, Article 2.6 of that regulation means ‘food containing, consisting of or produced from GMOs’. 96. The scope of Regulation No 1829/2003 is laid down in Article 3(1) thereof. It covers, firstly, GMOs for food use, secondly, food containing or consisting of GMOs and, thirdly, food produced from or containing ingredients produced from GMOs. The scope of the regulation is thus broad, excluding only food manufactured ‘with the help’ of a GMO. 97. Recital 16 in the preamble to Regulation 1829/2003 clarifies the distinction between food produced ‘from’ a GMO and food produced ‘with’ a GMO. According to that recital, the ‘determining criterion is whether or not material derived from the genetically modified source material is present (34) in the food’. (35) In the light of that criterion, the recital gives as an example of products obtained ‘with’ a GMO, and thus excluded from the scope of Regulation No 1829/2003, ‘products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products’. Indeed, at the present stage of scientific knowledge, it has not been proven that DNA present in genetically modified feed or, more broadly speaking, in material derived from such feed, or indeed in genetically modified medicinal products, can find its way into the meat of animals fed with such feed or treated with such medicine. 98. In view of that decisive criterion, that is to say, the presence in food of material derived from genetically modified source material, I take the view that both honey in which pollen from MON 810 maize is detected and pollen-based food supplements containing pollen from that same strain of maize must be regarded as foods produced ‘from’ GMOs. 99. Contrary to the position defended by the Commission, I consider that any distinction between those two types of food or any distinction between what is a natural constituent of honey and what is an ingredient is irrelevant to the question of their classification as foods ‘produced from GMOs’. 100. The Commission indeed takes the view that, while food supplements containing pollen derived from a GMO do fall within the scope of Regulation No 1829/2003 as foods produced from GMOs, that is not, however, the case for honey in which traces of pollen from a genetically modified plant are detected. Such pollen, it argues, should be regarded as a natural constituent of honey, not as an ingredient. 101. The Commission’s argument leads me to consider the wording of Article 3(1)(c) of Regulation no 1829/2003, which brings within its scope, ‘food produced from or containing ingredients produced from GMOs’. That provision thus develops, in so far as concerns food, (36) the definition contained in Article 2.10 of the regulation, referring as it does to ‘ingredients’. 102. It thus becomes necessary to consider whether pollen present in honey or used as a food supplement may be regarded as an ‘ingredient’ within the meaning of the definition given to that term in Article 2.13 of Regulation No 1829/2003, by reference to Article 6(4) of Directive 2000/13. According to the latter provision, an ‘ingredient’ is ‘any substance including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form’. 103. While it is easy to show that pollen contained in pollen-based food supplements is indisputably an ingredient, certain explanations are necessary in order to show the same with respect to pollen present in honey. 104. Annex II to Directive 2001/110 relating to honey sets out the ‘composition criteria for honey’. According to the first paragraph of that annex, honey consists not only of different sugars, but also of ‘other substances’ such as ‘solid particles derived from honey collection’. 105. According to the explanations furnished by Mr Bablok and Others, pollen, which is an important nutrient for young bees, is collected by bees from flowers with the help of their furry coat. They have on all their legs combs and brushes made of hair, which enable them to gather pollen and roll it into small balls. Inside the beehive, these pollen balls are released and deposited in special storage cells located on one surface of the honeycomb just next to the cells in which honey is stored. 106. In order to harvest the honey, the beekeeper takes the honeycombs from the beehive and centrifuges them, emptying the cells of their honey by centrifugal force. Inevitably, there will always be some pollen cells on the honeycombs and these too will empty along with the honey cells, thus mixing pollen into the honey. (37) 107. It is worth emphasising that, according to the third paragraph of Annex II to Directive 2001/110, ‘[w]ithout prejudice to Annex I, point 2(b)(viii), (38) no pollen or constituent particular to honey may be removed except where this is unavoidable in the removal of foreign inorganic or organic matter’. 108. It may be deduced from that provision that pollen is organic matter inherent in the composition of honey. It is not a foreign body or an impurity, but a normal constituent that may not, in principle, be removed. (39) The fact that it is a constituent of honey remains the case irrespective of when it is incorporated or what quantities of it are found in the honey, those factors being dependent upon certain variables during the honey’s manufacture and harvesting. 109. If we turn now to the notion of ‘ingredient’ as it appears from Article 6(4) of Directive 2000/13, it seems relatively straightforward to see that, at the same time as being a particular constituent of honey, pollen is also a substance ‘used in the manufacture or preparation’ of honey which is ‘still present in the finished product’. 110. The distinction which the Commission draws between ‘ingredients’ and ‘natural constituents’, apart from being theoretical in nature, would lead to the presence in honey of pollen from a genetically modified plant being excluded, which goes against the clear intention of the Community legislature as expressed in recital 16 in the preamble to Regulation No 1829/2003, to use as a decisive criterion the fact of whether or not material derived from genetically modified source material is present in the food. Moreover, if I had to agree, as the Commission proposes, that in order to be an ‘ingredient’ a substance must be incorporated into food by means of human intervention, then clearly the harvesting of honey by centrifuging, which has the effect of mixing the pollen into the honey, is precisely an act of that nature. 111. It can, in my opinion, also be easily acknowledged that pollen from MON 810 maize present in honey is an ingredient ‘produced from GMOs’ within the meaning of Article 3(1)(c) of Regulation No 1829/2003. Indeed, as prescribed by the definition given in Article 2.10 of the regulation, the pollen is ‘derived’ from a GMO and, in the light of the points made in response to the first question, it cannot be regarded as consisting of or containing a GMO. 112. Lastly, once it is accepted that pollen is an ingredient of honey, and that it is an ingredient produced from a GMO, then the honey in issue in the main proceedings must, in my view, be regarded, for the purposes of Article 3(1)(c) of Regulation No 1829/2003, as a food ‘containing’ such an ingredient. By virtue of that provision, therefore, the honey undoubtedly falls within the scope of the regulation. 113. It is of little importance in that connection, turning to the second part of the second question referred for a preliminary ruling, whether or not a beekeeper intended to incorporate pollen from a genetically modified plant into his honey. 114. The explanations of how pollen finds its way into honey demonstrate that its incorporation, in random amounts, is not the fruit of any desire of the beekeeper but the result of something that happens during the honey production process. 115. The applicability of Regulation No 1829/2003, which is triggered by the presence (an objective criterion) in food either of a GMO or of material produced from genetically modified source material, cannot be made conditional upon the subjective criterion of whether or not that presence was intended. Such a criterion would go against the objective of protecting human health pursued by the regulation, since the risk that a genetically modified food can pose to human health is not dependent on whether incorporation of the substance in question is intentional or unintentional. 116. Moreover, as Mr Bablok and Others rightly point out, a narrow interpretation of the expression ‘produced from GMOs’ that depended on a subjective criterion would have the result of limiting the scope of application of the provisions of Regulation No 1829/2003 relating to the labelling of genetically modified food in a manner contrary to their clear normative content. Indeed, under Article 12(1)(b) of that regulation, food produced from a GMO must be labelled as such. That labelling requirement only ceases to apply where the proportion of the material derived from a GMO is 0.9% or less, provided that its presence is adventitious or technically unavoidable. The stipulation of that last condition would have no sense if the adventitious or technically unavoidable nature of the presence in food of GMO-derived material meant that the food was no longer ‘produced from GMOs’ and, as such, was excluded from the scope of Regulation No 1829/2003. 117. I deduce from all the foregoing considerations that Article 2.1 of Regulation No 1829/2003 must be interpreted as meaning that it is sufficient, in order for it to be considered that a food is ‘produced from GMOs’, that it contains material from genetically modified plants. Moreover, Article 3(1)(c) of that regulation must be interpreted as meaning that honey containing pollen from a genetically modified plant, and also food supplements derived from such pollen, are foods containing ingredients produced from GMOs. It is irrelevant, in that connection, whether the genetically modified plant material incorporated into the food is incorporated intentionally or otherwise. 118. Lastly, it is necessary to answer the argument that honey is a product of animal origin and as such does not fall within the scope of Regulation No 1829/2003. The referring court refers, in that regard, to an opinion expressed by the Standing Committee on the Food Chain and Animal Health at a meeting on 23 June 2004 to the effect that honey, being a product of animal origin, does not fall within the scope of the regulation unless it is produced by genetically modified bees. That is not, in my view, a decisive condition. 119. It is clear from point 1 of Annex I to Directive 2001/110 that, while honey is indeed a substance produced by bees, the source material is both vegetable (the nectar of plants and secretions of the living parts of plants) and animal (excretions of plant-sucking insects on plants). Moreover, it has been seen that, according to the first paragraph of Annex II to that directive, ‘honey consists [inter alia] of solid particles derived from honey collection’, and I have already had occasion to say that the decisive criterion which will bring honey within the scope of Regulation No 1829/2003 is whether or not it contains material derived from a genetically modified plant, in this case pollen. (40) 120. Moreover, I do not share the Commission’s view that recital 16 in the preamble to Regulation No 1829/2003 should be read as meaning that all products of animal origin are excluded from its scope. The sole purpose of the examples given in that recital by the Community legislature, such as products obtained from animals fed with genetically modified feed, is to illustrate what falls into the category of food produced ‘with’ a GMO in which no material derived from genetically modified source material may be detected. They cannot, in my opinion, serve to express the desire of the Community legislature to exclude from the scope of Regulation No 1829/2003 products of animal origin which, like honey, may contain material produced from genetically modified source material. 121. Having completed my analysis of the first two questions referred for a preliminary ruling, I think it useful to summarise my reading of the subdivisions of Article 3(1) of Regulation No 1829/2003, whose purpose is to define the scope of the regulation. 122. As I stated in the context of my analysis of the first question, only living organisms or, if one prefers, biologically active organisms, can be GMOs. Thus, the categories described in Article 3(1)(a) (‘GMOs for food use’) and in Article 3(1)(b) (‘food containing or consisting of GMOs’) of the regulation require the presence of living organisms, that is to say, organisms still able to replicate or transfer genetic material. 123. As soon as a food contains inanimate or dead fragments derived from a GMO, it falls within the scope of Regulation No 1829/2003 by virtue of Article 3(1)(c) thereof. It must also, in accordance with Article 2.10 of the regulation, be regarded as ‘derived, in whole or in part, from GMOs, but not containing or consisting of GMOs’. 124. It is important in this context to emphasise the fact that, in accordance with recital 16 in the preamble to Regulation No 1829/2003, the deciding characteristic which will bring a food within that category is the presence within it of material derived from genetically modified source material. That last expression goes beyond the mere presence of genetic material in the strict sense, which specifically means nucleic acids that contain functional heredity units (DNA). It covers, more broadly, material of vegetable, animal or other origin, which is derived from a GMO and which may or may not still contain genetically modified DNA or genetically modified proteins. The continued presence of genetic material in food is difficult to predict and varies for each type of food, depending on whether or not the process by which the genetically modified source material is transformed results in the destruction of the genetic material. (41) 125. The division which can thus be made into the three categories of food preserves the utility of the last of those categories. Indeed, if one had to accept that the first and second categories also included GMOs or parts of biologically inactive GMOs, the category ‘food produced from or containing ingredients produced from GMOs’ would be limited to food in which no DNA could be detected. However, as recital 21 in the preamble to Regulation No 1829/2003 in particular suggests, in relation to labelling, the Community legislature seems not to have wanted account to be taken of whether or not genetically modified DNA or genetically modified protein can be detected in the final product. 126. By departing from the criteria of the presence of DNA or proteins derived from genetic modification in the final product, which formerly applied (as Regulation No 1139/98, for example, bears witness), the Community legislature thus sought to broaden the scope of Regulation No 1829/2003 so as to include, by means of Article 3(1)(c), all products derived from GMOs, irrespective of whether or not DNA or proteins derived from genetic modification are present in the final product. C – Consideration of the third question 127. In its order for reference, the Bayerischer Verwaltungsgerichtshof poses the question whether the combined provisions of Article 3(1) and 4(2) of Regulation No 1829/2003 may, contrary to their wording, be interpreted restrictively as meaning that the requirement for a marketing authorisation does not apply to foodstuffs such as honey which contain very small amounts, hardly above the threshold of detection, of material from genetically modified plants, in this case, pollen from the genetically modified MON 810 strain of maize. 128. It states that the principle of proportionality, as expressed in recital 24 in the preamble to the regulation in relation to labelling, may justify a restrictive interpretation of the authorisation provisions of the regulation. It observes that contamination, at very low levels, through transgenic maize pollen only arises inadvertently and is in practice unavoidable where genetically modified maize is planted across a large area. 129. The referring court also states that since, when authorisation to be placed on the market was granted pursuant to Directive 90/220, the MON 810 strain of maize underwent a risk assessment that took into account all potentially adverse effects on the environment, it might be compatible with the protective purpose of the regulation to allow the placing on the market of honey containing MON 810 pollen below a certain threshold to fall outside the prohibition of Article 4(2) of Regulation (EC) No 1829/2003. In addition, various foodstuffs produced from MON 810 maize or containing ingredients produced from MON 810 maize, such as maize flour and maize gluten, have already been granted Community authorisation. 130. The Bayerischer Verwaltungsgerichtshof nevertheless acknowledges that the wording and general structure of Regulation No 1829/2003, as well as the objective of protecting health pursued by that regulation, might preclude such a restrictive interpretation of the authorisation requirement laid down in Article 4(2) therein. 131. In short, by its third question, the referring court seeks, in essence, a ruling from the Court as to whether or not Articles 3(1) and 4(2) of Regulation No 1829/2003 must be interpreted as meaning that the adventitious presence in honey of pollen from a variety of maize such as MON 810 maize, which has been authorised for placing on the market pursuant to Directive 90/220 and of which only certain derived products have been authorised as existing products pursuant to Article 8(1)(a) of Regulation No 1829/2003, means that that honey must be authorised before it is placed on the market. The referring court asks this Court to state whether it is possible, in connection with the requirement for marketing authorisation arising under Article 4(2) of the regulation, to apply, by analogy, the tolerance thresholds laid down in Articles 12(2) and 47(1) thereof. 132. In order to answer that question, which concerns the particular case of honey containing pollen from MON 810 maize, (42) it is necessary first of all to ascertain the legal status of that plant variety and its food derivatives in the light of the Community rules both on the voluntary release of GMOs into the environment and on genetically modified food. 133. In so far as concerns the deliberate release of GMOs into the environment, that is to say, principally, the cultivation of GMOs, MON 810 maize was the subject of Decision 98/294/EC, adopted on the basis of Directive 90/220, which, it should be remembered, was repealed and replaced by Directive 2001/18. 134. In so far as concerns foodstuffs, a number of products derived from the MON 810 strain were authorised pursuant to Regulation No 258/97 and were subsequently notified as existing products in accordance with Article 8(1)(a) of Regulation No 1829/2003. (43) Those derived products are maize flour, maize gluten, maize meal, maize starch, maize glucose and maize oil. 135. Under Article 11 of Regulation No 1829/2003, Monsanto applied for renewal of the authorisation relating to those products. That application is still pending. (44) In accordance with Article 11(4) of the regulation, the period of authorisation is automatically extended until a decision is taken. 136. Monsanto and the Polish Government maintain that, where a GMO is authorised under Directive 2001/18, or under the preceding legislation, namely Directive 90/220, this means that all the potential effects which cultivation of that GMO may have on the environment have been assessed, including the consequences of the dissemination of pollen from genetically modified plants and the contamination of foodstuffs, such as honey, by such pollen. The situation does not, therefore, require a new marketing authorisation under Article 4(2) of Regulation No 1829/2003. 137. I do not share that view. Indeed, I do not think that an authorisation issued under Directive 2001/18 addresses all the repercussions of the release or placing on the market of a GMO. If that were the case, the utility of Regulation No 1829/2003 would be called into question and GMOs could, without any restriction or any specific food safety assessment, constitute foods or be incorporated into food. 138. Directive 2001/18 is a legislative act that has horizontal effect. It applies wherever there is no specific legislation to govern the use of GMOs in a given sector. Its primary purpose is, as its title suggests, the assessment of the potential effects of GMOs on the environment prior to their authorisation for release into the environment. 139. Regulation No 1829/2003, for its part, is sectoral legislation that specifically addresses genetically modified food. In accordance with its objective, the regulation provides, first and foremost, for scientific assessment of the risks that such food may pose to human and animal health. Assessment of the risks posed to the environment is not ruled out, but will not routinely take place. (45) 140. Directive 2001/18 and Regulation No 1829/2003 thus appear to be complementary legislative acts, the first focusing upon the risks arising from the voluntary release of GMOs into the environment, the second being more concerned with the risks posed by genetically modified food to human and animal health. Given how specific the analytical framework laid down by Regulation No 1829/2003 is, it cannot be considered that an authorisation to place a GMO on the market issued pursuant to Directive 2001/18 can cover all foods containing, consisting of, or produced from that GMO. In other words, authorisation granted under Directive 2001/18 has no effect upon the ‘safety assessment’ of genetically modified food that must, in accordance with the wording of recital 3 in the preamble thereto, be carried out under Regulation No 1829/2003. 141. It is clear from Article 4(2) of that regulation that whenever a GMO for food use or food referred to in Article 3(1) thereof is placed on the market, an authorisation issued in accordance with section 1 of Chapter II of Regulation No 1829/2003 must be obtained and the relevant conditions of the authorisation must be satisfied. 142. This may be a new authorisation granted under Article 7 of the regulation, or the extension of a product authorisation granted earlier, under the rules which apply to existing products in accordance with Article 8 of the regulation. 143. Moreover, according to recital 11 in the preamble to Regulation No 1829/2003, ‘where a GMO used in the production of food and/or feed has been authorised under [the regulation], foods and/or feed containing, consisting of or produced from that GMO will not need an authorisation under [the regulation], but will be subject to the requirements referred to in the authorisation granted in respect of the GMO’. 144. Can one, therefore, take the view that honey containing traces of pollen from MON 810 maize is a genetically modified food that may be regarded as having been duly authorised under Regulation No 1829/2003? 145. I would be inclined the answer that question in the affirmative if there were a decision of the Commission authorising, without stipulating any particular list or restrictions, food produced from a genetically modified plant such as MON 810 maize, along the lines, for example, of Commission Decision 2009/866/EC of 30 November 2009 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604 (SYN‑IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003. (46) 146. That, however, is not the case with MON 810 maize. The only derivatives that may be regarded as authorised under the regulation are maize flour, maize gluten, maize meal, maize starch, maize glucose and maize oil. I cannot rule out the possibility that the restriction of the authorisation to those particular products is significant in terms of food safety and I therefore prefer to regard it as not being comparable to a general authorisation to place on the market food produced from MON 810 maize. 147. Given the present state of the authorisations relating to MON 810 maize and its derivatives, I take the view that any food, other than the types mentioned above, that may be regarded as being produced from that plant variety should be authorised before they are placed on the market pursuant to Regulation No 1829/2003. If that requirement seems excessive in comparison with the risks which products derived from MON 810 maize pose to human health, it is a matter for the competent authorities to grant a general authorisation for the placing on the market of foods produced from that variety of genetically modified maize. 148. In any event, the inconveniences and practical difficulties to which that requirement for a marketing authorisation may give rise cannot be remedied by interpreting Regulation No 1829/2003 in such a way as to introduce a tolerance threshold which would enable an operator to dispense with such an authorisation. 149. Tolerance thresholds are nevertheless not totally absent from the regulation. They do, however, apply to certain well-defined cases. 150. First of all, Article 12(2) of Regulation No 1829/2003 provides that the labelling requirement does ‘not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0.9 per cent of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable’. That tolerance threshold applies solely to the obligation to label genetically modified food. It cannot, therefore, in the absence of any indication to that effect on the part of the Community legislature, be applied by analogy to the obligation to obtain a marketing authorisation which arises under Article 4(2) of the regulation. 151. Secondly, Article 47(1) of the same regulation introduces a threshold of 0.5% in respect of the adventitious or technically unavoidable presence in food of genetically modified material that has not been authorised in accordance with Community legislation, but which has undergone a risk assessment and has the benefit of a favourable opinion from the competent authorities. The provision states in relation to food that, if this presence does not exceed a proportion of 0.5%, there is no infringement of Article 4(2) of the regulation. 152. This is, indeed, an exception to the requirement to obtain a marketing authorisation, but it is merely a transitional measure (47) that applies, as is stated in Article 47(5) of Regulation No 1829/2003, for a period of three years following the date of application of the regulation. It cannot, therefore, be applied by analogy to a situation such as that in issue in the present case. 153. Given the current state of European Union rules relating to GMOs, it falls, by virtue of the principle of subsidiarity, to the national authorities to lay down rules and to prescribe procedural mechanisms to lessen the inconvenience that may arise from the coexistence of genetically modified crops and traditional agriculture where the solution to such problems does not flow directly from European Union law. Compensation for the financial losses sustained by a beekeeper who finds himself prevented from placing his products on the market is one such solution. IV – Conclusion 154. In the light of the foregoing considerations, I propose that the Court reply as follows to the questions referred for a preliminary ruling by the Bayerischer Verwaltungsgerichtshof: (1) Article 2(1) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, and Article 2.4 of Regulation No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, must be interpreted as meaning that pollen from a genetically modified plant, which, when it is incorporated into honey or is used as a food supplement, is no longer capable of fulfilling its role in the plant reproduction process, is not an ‘organism’ within the meaning of those provisions. (2) Article 2.10 of Regulation No 1829/2003 must be interpreted as meaning that it is sufficient, in order for food to be considered as being ‘produced from [genetically modified organisms]’, that it contain material from genetically modified plants. Moreover, Article 3(1)(c) of that regulation is to interpreted as meaning that honey containing pollen from a genetically modified plant, and also food supplements derived from such pollen, are foods containing ingredients produced from genetically modified organisms. It is irrelevant in that regard whether the genetically modified plant material is incorporated intentionally or otherwise. (3) Articles 3(1) and 4(2) of Regulation No 1829/2003 must be interpreted as meaning that the accidental presence in honey of pollen from a strain of maize, such as MON 810 maize, which has been authorised to be placed on the market pursuant to Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, and of which only certain derived products have been authorised as existing products pursuant to Article 8(1)(a) of that regulation, has the consequence that the placing of that honey on the market requires an authorisation issued in accordance with that regulation. The tolerance thresholds laid down in Articles 12(2) and 47(1) of Regulation No 1829/2003 may not be applied by analogy to the requirement for a marketing authorisation arising under Article 4(2) of that regulation. 1 – Original language: French. 2 – OJ 2003 L 268, p. 1. 3 – Messrs Bablok, Egeter, Stegmeier and Müller, and Ms Klimesch (‘Mr Bablok and Others’). 4– ‘GMOs’. 5 – OJ 2001 L 106, p. 1. 6 – OJ 1990 L 117, p. 15. 7 – OJ 2003 L 268, p. 24 (‘Directive 2001/18’). 8– The Cartagena Protocol on Biosafety to the Convention on Biological Diversity, concluded in Montreal on 29 January 2000 (‘the Protocol’). 9 – The Convention was opened for signature at the United Nations Conference on Environment and Development (UNCED) held in Rio de Janeiro on 5 June 1992. It entered into force on 29 December 1993. 10 – ‘the Authority’. 11 – OJ 2000 L 109, p. 29. 12 – OJ 2002 L 31, p. 1. 13– OJ 1997 L 43, p. 1. 14 – OJ 2002 L 10, p. 47. 15 – BGBl. 2005 I, p. 186. 16 – BGBl. 2002 I, p. 42. 17 – OJ 1998 L 131, p. 32. 18 – In implementation of Article 1 of that decision and in accordance with Article 13(4) of the directive, the French Minister for Agriculture and Fisheries gave, by order of 3 August 1998, its written consent to the placing of this maize on the market (see the Order of 3 August 1998 giving written consent, pursuant to Article 13(4) of Directive 90/220/EEC of 23 April 1990 and Decisions 98/293/EC and 98/294/EC of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T 25 and MON 810 (JORF, 5 August 1998, p. 11985)). 19 – Mr Bablok and Others state that they seek an injunction against the Freistaat Bayern requiring it to take all appropriate measures to prevent the contamination of their apicultural products by MON 810 maize pollen and to remedy the resulting inability of the products concerned to be marketed and consumed. 20 – Mr Bablok and Others state that, on the basis of that ruling, they may only claim damages or an indemnity and that the Bayerisches Verwaltungsgericht Augsburg declined to recognise any right to protection or to have the disturbance brought to an end for the reason that, in this particular case, the interests worthy of protection (namely crop growing for research purposes) took precedence. 21 – Emphasis added. 22 – OJ 2003 L 287, p. 1. 23 – See, to that effect, Mackenzie, R., and Others, An Explanatory Guide to the Cartagena Protocol on Biosafety, p. 58, paragraph 205. The text may be consulted at the following website: http://www.unep.org/biosafety/files/IUCNGuide%20on%20the%20CPB.pdf. 24 – OJ 2009 L 125, p. 75. In Article 2(a) of the directive, ‘micro-organism’ is defined as ‘any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture’. 25 – See Mackenzie, R., and Others, p. 57, paragraph 204. 26 – Handbook for the implementation of Directive 90/220/EEC on the deliberate release of genetically modified organisms into the environment, vol. I, May 1992, p. 17. 27 – Emphasis added. 28 – English original text. 29 – OJ 2002 L 200, p. 22. 30 – Idem, pp. 28 and 29. The risk arising from the horizontal transfer of genes is thus one of the events to be taken into account in any GMO assessment. That does not, however, mean that it is something that defines a GMO. 31 – See also, to that effect, recital 3 in the preamble to Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC (OJ 1998 L 159, p. 4), which states that Directive 90/220, which Directive 2001/18 replaced without altering its scope, ‘does not cover non-viable products derived from [GMOs]’. 32 – I would also add, as a further argument in support of the view that GMOs are living organisms, that, in its draft recommendation for second reading of the Council common position for adopting a European Parliament and Council regulation on genetically modified food and feed, the European Parliament stated, when referring to the category of food and feed which contains or consists of GMOs, that this means ‘living GMOs’ (see paragraph (b) of the explanatory statement, p. 34). 33 – In the same manner as other undesirable consequences such as allergies. 34 – Emphasis added. 35 – The explanatory memorandum for the proposal for a regulation of the European Parliament and of the Council on genetically modified food and feed (COM(2001) 425 final) explains that the proposal ‘would cover products “produced from a GMO”, but not products “produced with a GMO”. The former implies that a proportion of the end product, whether it is the food or feed itself or one of its ingredients, has been derived from the original genetically modified material. The latter is produced with the assistance of a [GMO], but no material derived from the [GMO] is present in the end product’. The proposal gives as an example of the latter category cheese produced with a genetically modified enzyme that does not remain in the final product (p. 4). 36 – By contrast, in the case of genetically modified feed, Article 15(1)(c) of the regulation makes no mention of ‘ingredients’. 37 – In so far as concerns pollen intended for food use as a food supplement, Mr Bablok and Others explain that the pollen is obtained by means of ‘pollen traps’ placed at the entrance to the hives. These are, in essence, a grill through which the honey bees returning to the hive must force their way, leaving behind their pollen sacs which are rubbed off. The pollen balls fall into a receptacle and are then collected, cleaned and dried. 38 – That provision concerns the particular case of filtered honey, that is to say, honey obtained by removing foreign inorganic or organic matter in such a way as to result in the significant removal of pollen. Recital 6 in the preamble to Directive 2001/110 states that the consumer must be correctly informed to that effect by means of an appropriate indication on the label. 39 – The presence of pollen in honey makes it possible to identify the honey’s botanic origins. Melissopalynology, or the study of pollen presence in honey, is used to identify compositions and detect fakes and is also used in the labelling of certified content honey. 40 – The question could equally be addressed from the point of view of the presence in honey of nectar from a genetically modified plant. That question does not, however, arise in the present case, since MON 810 maize produces no nectar. 41 – By way of example, a highly refined product such as oil obtained from genetically modified maize will most likely no longer contain any trace of DNA. However, such a product continues to be governed by Article 3(1)(c) of Regulation No 1829/2003. 42 – However, the points which follow apply equally to pollen-based food supplements. 43 – I shall limit myself to referring to the notifications of foodstuffs and omit notifications of feed produced from MON 810 maize. For a more complete picture, reference should be had to the Community register of genetically modified foods and feed available at the following website: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm. 44 – See, in that regard, the scientific opinion of the Authority on that application (EFSA Journal [2009] 1149, p. 1), available at the following website: http://www.efsa.europa.eu/en/efsajournal/pub/1192.htm. 45 – There will be such an assessment in the case of GMOs and foods containing or consisting of GMOs (see, inter alia, Articles 5(5) and 6(4) of Regulation No 1829/2003). 46 – OJ 2009 L 314, p. 102. 47 – See recital 26 in the preamble to Regulation No 1829/2003.