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B — Powers of the Member States to adopt protective measures against the placing on the market of novel foods (second question referred for a preliminary ruling) I- 8 1 4 0 I- 1. Submissions by the parties 8140 I 8142 2. Appraisal - (a) Preliminary observations on the justification of national measures by direct reference to the precautionary principle I- 8142 (b) Powers of the Member States to adopt protective measures on the basis of Regulation No 258/97 I- 8144 (i) The second subparagraph of Article 3(4) in conjunction with Article 13 I- 8145 (ii) Article 12 I- 8148 C — Classification of the action by the Commission under the simplified procedure (third question referred for a preliminary ruling) I- 8153 1. Arguments of the parties I - 8153 2. Assessment I - 8153 D — Validity of Article 5 of Regulation No 258/97 (fourth question referred for a preliminary ruling) I - 8155 1. Arguments of the parties I - 8155 2. Appraisal I - 8158 I V — Conclusion - 8164

I — Introduction merely requires a notification to the Com- mission.

1. The present reference for a preliminary ruling essentially concerns the question 2. Foods produced from genetically modi- whether Italy was right to prohibit foods fied organisms but which no longer contain made from genetically modified maize t h e m m a y , u n d e r R e g u l a t i o n (EC) which were placed on the market under N o 258/97 of the European Parliament the so-called simplified procedure, which and of the Council of 27 January 1997

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3. Monsanto Europe SA and two other firms used the simplified procedure in 1997 and 1998 to notify the placing on the 5. The T r i b u n a l e A m m i n i s t r a t i v o market of foods made from genetically Regionale (Regional Administrative Court) modified maize. The competent United del Lazio (Italy), before which the case was Kingdom food authority had previously brought, questions the admissibility of the certified substantial equivalence. simplified procedure in those specific cases, since there are indications that residues of transgenic protein are contained in the foods. In addition, it questions whether that procedure is compatible with Articles 153 and 174 EC and takes suffi- cient account of the precautionary principle and other principles of Community law. It also points out that novel foods can in that way be placed on the market, with effects for the entire Community, although no full risk assessment, with the participation of 4. The Italian Republic thereupon imposed all the Member States, has taken place. a temporary prohibition on the marketing Finally, it raises questions concerning the power of a Member State to prohibit the placing on the market of such foods within 2 — OJ 1997 L 43, p. 1. its own territory alone.

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I I— Legal background the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.

A — Community law

1. Directive 90/220/EEC 3

OPINION OF MR ALBER — CASE C-236/01

8. Article 1 defines the scope of the regu- 9. Article 3 provides: lation as follows:

' 1 . Foods and food ingredients falling ' 1 . This Regulation concerns the placing on within the scope of this Regulation must the market within the Community of novel not: foods or novel food ingredients.

— present a danger for the consumer, 2. This Regulation shall apply to the plac- ing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Commu- nity and which fall under the following categories: — mislead the consumer,

(a) foods and food ingredients containing — differ from foods or food ingredients or consisting of genetically modified which they are intended to replace to o r g a n i s m s w i t h i n the meaning of such an extent that their normal con- Directive 90/220/EEC; sumption would be nutritionally dis- advantageous for the consumer.

(b) foods and food ingredients produced from, but not containing, genetically 2. For the purpose of placing the foods and modified organisms; food ingredients falling within the scope of this regulation on the market within the Community, the procedures laid down in Articles 4, 6, 7 and 8 4 shall apply on the

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trade in and use of the food or food 2. Matters shall be referred to the Com- ingredient in question in its territory. It mittee by the Chairman either on his own shall immediately inform the other initiative or at the request of the represen- Member States and the Commission tative of a Member State. thereof, giving the grounds for its decision.

3. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall 2. The Commission shall examine the deliver its opinion on the draft within a grounds referred to in paragraph 1 as soon time limit which the Chairman may lay as possible within the Standing Committee down according to the urgency of the for Foodstuffs; it shall take the appropriate matter. The opinion shall be delivered by measures in accordance with the procedure the majority laid down in Article 148(2) of laid down in Article 13. The Member State the Treaty in the case of decisions which which took the decision referred to in the Council is required to adopt on a paragraph 1 may maintain it until the proposal from the Commission. The votes measures have entered into force.' of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.

12. Finally, Article 13 lays down the fol- lowing procedural rules for the Commis- 4. (a) The Commission shall adopt the sion: measures envisaged if they are in accordance with the opinion of the Committee.

... If a NF (novel food) has not been found to be substantially equivalent to an existing food or food component, this does not imply that it is unsafe. It just indicates that 14. Part I, point 3(3) of the Annex to such a NF should be evaluated on the basis Recommendation 97/618 sets out the con- of its unique composition and properties. cept of substantial equivalence as follows:

'The concept of "substantial equivalence" ...' has been introduced by WHO (the World Health Organisation) and OECD (the Organisation for Economic Cooperation and Development) with particular refer- ence to foods produced by modern biotech- nology. In the terminology of the OECD, the concept of substantial equivalence embodies the idea that existing organisms 15. Part I, point 3(7) in the Annex, entitled used as foods or as food sources can serve 'Toxicological requirements', states: as a basis for comparison when assessing the safety of human consumption of a food or food component that has been modified or is new. If a new food or food component

8 — Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the plac- ing on the market of novel foods and novel food ingredients 'In principle, the toxicological require- and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and ments for NF need to be considered on a of the Council (OJ 1997 L 253, p. 1). case-by-case basis. In establishing the need

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16. In order to assess the substantial equiv- alence of genetically modified plants, Part I, point 5 (Identification of essential infor- mation for assessment of wholesomeness), subsection IV (Effect of the genetic modi- fication on the properties of the host organism) of the annex to Recommen- ...'

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B — Italian legislation 19. By two decisions of 22 April 1998, the Commission authorised, on the basis of Article 13 of the deliberate release direc- tive, the placing on the market of maize kernels from the lines Bt-11 and MON 810 — u n d e r A r t i c l e 1 of b o t h decisions — without prejudice to Regu- 17. The Prime Ministerial Decree of lation No 258/97. 10 4 August 2000 on the precautionary sus- pension of the marketing and use of certain transgenic products within the national territory under Article 12 of Regulation No 258/97 9 (hereinafter 'the Decree') sus- pends the marketing and use of products derived from transgenic maize of the lines 20. In parallel to the procedure under the Bt-11, MON 810 and MON 809. deliberate release directive, on 10 December 1997 Monsanto Europe SA notified the Commission under the simplified pro- cedure laid down in Article 5 of Regulation No 258/97 of the placing on the market of foods containing flour and other products from genetically modified maize of the line MON 810. Similar notifications were sub- sequently submitted on 30 January 1998 and on 14 October 1998 by Novartis Seeds I I I— Facts of the case and proceedings AG with respect to products derived from Bt-11 maize and by Pioneer Overseas Cor- poration with respect to products derived from MON 809 maize.

inserted into Bt-11 and MON 809 render considered it appropriate to use that pro- the maize resistant to certain herbicides. cedure for the last time even after that date for products derived from MON 809 maize and Bt-11 maize, since products derived from similar maize lines had already been placed on the market under the simplified procedure and the applicant had already received a positive opinion from the United 22. The notifications to the Commission Kingdom food assessment bodies in Feb- were accompanied by the opinions of the ruary 1997. United Kingdom Advisory Committee on Novel Foods and Processes (ACNFP) of September 1996, which the United King- dom Ministry of Agriculture, Fisheries and Food forwarded to the companies by letter of 14 February 1997. The ACNFP con- cluded in those opinions that the foods derived from the genetically modified maize lines in question were substantially equivalent to products from conventional 25. By letters of 23 November 1998, maize. 4 February 1999 and 2 April 1999 to the Commission, the Italian health ministry called for the use of the authorisation procedure and asked to see the toxicologi- cal and allergenicity assessments for the products. The Commission did not reply to those letters itself. It took the letters as requests for information, which, in accord- 23. The Commission forwarded the notifi- ance with its practice, it forwarded to the cations to the Member States on 5 and firms, for them to make the information 6 February 1998, and on 23 October 1998, which had been requested immediately and published them in the Official journal available to the Member State. of the European Communities. 11

29. The Scientific Committee for Food came to the conclusion, in its opinion of 7 September 2000, that the evidence put forward in the Italian opinions of 16 December 1999 and 28 July 2000 did not provide detailed scientific grounds for considering that human health was endan- 27. In opinions by the Italian Consiglio gered. Superiore di Sanità of 16 December 1999 and by the Italian Istituto Superiore di Sanità (hereinafter 'ISS') of 4 and 28 July 2000, those institutes also expressed their reservations about the substantial equival- ence of the products derived from geneti- 30. The Commission refrained from adopt- cally modified maize. That maize contained ing a measure concerning that decree under between 0.04 and 0.30 parts per million of Article 12(2) in conjunction with Article 13 transgenic protein. Nevertheless, the ISS of Regulation No 258/97, since its draft excluded any health risk to people or decision had received no support in the animals on the basis of the available Standing Committee for Foodstuffs. On the scientific knowledge. contrary, in the committee meetings that took place on 18 and 19 October 2000, several Member States expressed concern at the use of the simplified procedure for products derived from genetically modified organisms. Before adopting a decision con- cerning the Decree, clarification was necessary in respect of the criterion of substantial equivalence.

28. On the basis of Article 12 of Regu- lation No 258/97, on 4 August 2000 the Italian Republic adopted the Decree referred to in paragraph 16. In support of the Decree it explained, inter alia, that the 31. Monsanto and others and the Associa- absence of detailed information and the zione Nationale per lo Svilupo delle Bio- renewed interest by the Scientific Commit- tecnologie (Assobiotec, the national Associ- tee for Food gave rise to circumstances ation for the Development of Biotechnol- which provided grounds for the temporary ogy) brought an action on 13 November suspension of marketing. The Italian 2000 before the Tribunale Amministrativo

— for the allocation of the burden of proof as regards risks to human health and the environment arising (1) Is Article 3(4) of Regulation No 258/97 from the new product? of the European Parliament and of the Council concerning novel foods and novel food ingredients to be interpreted to mean that foods and food ingredi- e n t s w i t h i n t h e m e a n i n g of Article 1(2)(b) of the Regulation are to be considered substantially equival- ent to existing foods and food ingredi- ents and may therefore be placed on (3) Does it affect the answer to the second the market by means of the simplified question if the simplified procedure is procedure, following a notification in assumed to constitute tacit consent by accordance with Article 5 of the regu- the Commission, and does it follow lation, even if those foods and food that such tacit consent must be con- ingredients contain residues of trans- sidered unlawful if the answer to the genic protein? second question is negative?

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(4) If the answer to the first question is and the environment, as can be affirmative, is Article 5 of Regulation generally deduced from Recom- No 258/97 compatible with mendation 97/618/EC? Articles 153 and 174 EC, as well as with the precautionary principle and the principles of proportionality and reasonableness, in so far as 33. Monsanto and others, the Italian and Norwegian Governments, the European Parliament, the Council and the Commis- sion have submitted observations to the Court. The contents of their observations are presented in the context of the legal assessment of the individual questions referred.

36. The concept of substantial equivalence, as developed in various fora (FAO/WHO and OECD, the United Nations Food and Agriculture Organisation and World 39. The Norwegian Government analyses Health Organisation and the Organisation various sources which develop and inter- for Economic Cooperation and Develop- pret the concept of substantial equivalence; ment) and taken up in Recommendation in particular, it refers to Points 3.3 and 3.7 97/618, does not require the foods being of Recommendation 97/618, the summary compared to be identical. For that reason, records of the meetings on 18 and the presence of transgenic protein in prod- 19 October 2000 of the Standing Com- ucts produced from genetically modified mittee on Foodstuffs, the various reports of organisms does not preclude substantial the FAO/WHO and the OECD and an equivalence. evaluation carried out by the International Life Science Institute (ILSI) in 1996.

37. The Italian Government argues that the simplified procedure can apply only where substantial equivalence has been estab- lished. That is a scientific rather than a legal question. As Point 3.3 of Recommen- 40. The Norwegian Government draws the dation 97/618 implies, the criterion of following conclusions from those docu- substantial equivalence is instrumental in ments: character and is present only where the factors (composition, nutritional value, etc.) mentioned in Regulation No 258/97 concur.

— The establishment of substantial equiv- alence is not a safety assessment in 38. The ISS determined, however, that itself, but merely the starting point for traces of the protein encoded by the the safety assessment.

— There is a certain degree of freedom in choosing the elements to be compared, with respect to the food source, the food product and molecular levels. 42. According to the European Parliament, the question of substantial equivalence and the applicability of the simplified procedure is a question of fact, which the referring court must decide. — Plants or foods containing an inserted trait which does not occur naturally in the parent plant could be considered substantially equivalent except for the inserted trait, which should then be the focus of safety testing. 43. The Commission, in a first step, states that the products in question merely con- tain transgenic protein but are not geneti- cally modified organisms capable of repro- duction. The applicability of Article 5 of — Further, consensus is needed on the Regulation No 258/97 is therefore in practical application of the principle of principle established. substantial equivalence.

41. The Norwegian Government is of the 44. Regulation No 258/97 and Recommen- opinion that a separate study of the genetic dation 97/618 contain criteria for estab-

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(a) Preliminary observation on the facts of 45. In the meantime, it is no longer possible the case and the interpretation of the to consider foods which contain transgenic questions referred protein as traditional food without further examination. At the time when the placing on the market of the contested foods was notified, however, substantial equivalence 47. It cannot be clearly inferred, either was still assumed, so that the use of the from the order for reference or from the simplified procedure in that case was papers in the case, which specific foods or justified in view of the legal situation and food ingredients from the three genetically the state of science at the time. Moreover, it modified maize lines at issue were placed was undisputed that the foods did not on the market, nor precisely what their represent a threat to the environment or to purpose is. It appears essentially to involve human health. flour.

12 — The Commission refers in that connection to the work of the FAO and W H O . In addition, it cites two reports by the O E C D : the Report of the OECD workshop on the toxicological and nutritional testing of novel foods (1998) and the Report of the task force for safety of novel foods and feeds (2000). 13 — Proposal for a Regulation of the European Parliament and 48. In any event, those involved agree that of the Council on genetically modified food and feed of 25 July 2 0 0 1 , COM(2001) 425 final; printed without the production processes for those foods — explanatory memorandum in OJ 2001 C 304 E, p. 2 2 1 . the ACNFP refers to dry milling and wet

50. The representatives of Monsanto and others have admitted, in the oral procedure, that foods derived from genetically modi- fied maize could in fact contain represen- tative traces. However, those were small amounts of transgenic protein, from 0.04 to 0.30 ppm. That value, which is men- 52. The question of the interpretation of tioned in the recitals of the Decree and in the concept of substantial equivalence is a the ISS opinion of 4 July 2000, to which the national court refers, 14 relates to represen- tative traces in maize plants before their 15 — An underlying question is whether denatured proteins may perhaps also pose risks, such as provoking allergies. For it processing into maize flour. However, was not disputed in the findings that, in any event, small processing results in the denaturation of amounts of transgenic proteins in non-denatured form are also present in the foods. 16 — ACNFP opinions (communicated by letter of 14 February 1997) on the substantial equivalence of products derived from maize lines M O N 809 (paragraph 17), M O N 810 14 — Paragraph 9 of the order for reference. (paragraph 20) and Bt-11 (paragraph 20).

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5 3 . A c c o r d i n g to the w o r d i n g of Article 3(4) of Regulation No 258/97, sub- stantial equivalence is to be determined on 55. If substances expressed by the inserted the basis of a comparison between food gene are also included in the comparison, it produced from genetically modified maize is clear that the novel food in any event and corresponding products made from differs from its conventional counterpart conventional maize. The comparison is to inasmuch as those materials have not been consider their composition, nutritional completely eliminated during the process- value, metabolism, intended use and the ing of the novel food. On the assumption level of undesirable substances contained that the transgenic protein in the present therein. case serves a particular purpose only during the growth phase of the maize plants, but not in the foods subsequently produced from those plants, they could be considered undesirable substances within the meaning of Article 3(4) of Regulation No 258/97. The presence of those undesirable sub- 54. It is not clear what the comparison is to stances would then constitute a further cover. It could perhaps be limited to difference between the conventional and comparing the concentration of basic com- the novel food.

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56. Two interpretations are possible in that fats, proteins, minerals, etc.) were con- situation: sidered innocuous. 17

17 — Analogous variations in composition also occur under natural conditions and represent a significant problem when comparing novel and traditional foods in order to 57. The wording of the Regulation at first determine substantial equivalence. The OECD has there- glance allows both interpretations. Since fore begun to draw up profiles for various useful plants, with details on constituents and their natural variations as substantial equivalence rather than identity a basis for comparison (see, for example, Consensus Document on Compositional Considerations for New or conformity of composition is at issue, Varieties of Maize (Zea Mays): Key Food and Feed the broader interpretation can be given Nutrients, Anti-nutrients and Secondary Plant Meta- bolites, OECD Environmental Health and Safety Pub- preference. On the other hand, the choice lications, Series on the Safety of Novel Foods and Feeds, N o 6, 2002). of that concept could also be explained by 18 — See generally, on the completion of the legislative pro- the fact that only variations within a cedure and the main points of contention during the development of Regulation N o 258/97: D. Groß, Die specific range with respect to the level of Produktzulassung von Novel Food, Berlin 2001, p. 133 et various constituents which are important seq. and p. 144 et seq., and R. Streinz, 'Der Stand der europäischen "Novel Food" - Diskussion', Zeitschrift für for nutritional physiology (carbohydrates, das gesamte Lebensmittelrecht, 1996, p. 123.

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original proposal of 1992. 19 Under that time, in connection with the simplified proposal, however, the regulation was in procedure, can be inferred from the state- any case to apply only to foods produced ment of reasons for the common position. by processes resulting in a significant That concept was not questioned or dis- change in their composition, nutritional cussed in subsequent procedures. Rather, value and/or their intended use. In addition the discussions concentrated mainly on to many other criticisms, the European labelling provisions. 22 Parliament in its first reading objected to the restriction of the field of application to clearly altered foods. 20

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(d) The scientific context of the concept of 1993 OECD report'), 25 developed the substantial equivalence determination of substantial equivalence as a first step in a safety assessment of food produced by biotechnology. 26 The starting point for that concept is the idea that mankind has for centuries gained experience of conventional foods. Even when conventional foods are not free of dangerous substances, there is none the less wide-ranging agreement that they can be considered safe, on the basis of that experi- ence and with regard to acquired knowl- edge. That same evaluation should apply to 63. The evaluation of novel foods presents a novel food which is substantially equiv- particular challenges. 24 Foodstuffs are as a alent to a conventional food. In particular, rule a complex mixture of various sub- the OECD proposes the following con- stances. In that respect, they differ from ditions for demonstrating substantial artificial food additives or from medicines, equivalence: which are composed of specific active ingredients. The toxicological effects or secondary effects of those substances, whose composition is precisely known, can be studied in isolation both in vitro and in vivo, for example through animal 'A demonstration of substantial equival- testing. On the other hand, animal feeding ence takes into consideration a number of studies using foods intended for human factors, such as: consumption are frequently unsuccessful because laboratory animals cannot tolerate a 'high dose' of that food purely for reasons of nutritional physiology.

Based on a consideration of the factors in the paragraph above, knowledge that a new food or food component(s) was derived from organism(s) whose newly introduced traits have been well-characterised, together with a conclusion that there is reasonable certainty of no harm as com- pared with its conventional or traditional 67. In 1996, a joint working group of the counterpart, means that a new food or food FAO (United Nations Food and Agriculture component(s) can be considered substan- Organisation) and the WHO (World tially equivalent.' Health Organisation) examined the topic and published the report Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety (hereinafter, the '1996 FAO/ WHO report'). 27 That report pointed out, first of all, that the determination of substantial equivalence is not in itself a 65. The obvious starting point of the OECD formulation is that the newly inserted trait and its expression products 27 — Available on the internet, www.fao.org/es/ESN/food/pdf/ must be taken into account when con- biotechnology.pdf.

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safety assessment. It is merely a dynamic traits, further safety assessments should analytical procedure to examine the safety focus on those traits. of novel foods in comparison with their traditional counterparts. For the expert groups, an examination of equivalence can lead to the three following results:

69. The participants in an OECD work- shop endorsed that position taken by the — The novel food is substantially equiv- FAO/WHO expert groups. 28 It is note- alent to the traditional one. worthy that in the report on that work- shop, plants which have developed resis- tance to certain insects as the result of the introduction of a Bacillus thuringensis gene were put forward as an example of the second category. 29 Plants thus modified, and products derived from those plants, are thus considered novel foods which are — There is substantial equivalence with substantially equivalent to their conven- the exception of specific traits. tional counterparts, with the exception of the newly introduced trait of insect resis- tance.

72. However, the concept continued to meet with criticism. 32 Objections were raised that it was too imprecise and merely served as a pretext to avoid having to carry out comprehensive toxicological and aller- genicity testing on novel foods. 33 Other criticism considered it a contradiction in terms to test foodstuffs known to differ 73. Independently of that criticism, it must from one another as the result of the be concluded that the work of the inter- insertion of a new trait for the purpose of national organisations described here has establishing their equivalence. 34 Finally, it not, in the final analysis, made it possible to was pointed out that testing for substantial answer the question whether equivalence equivalence by comparing composition within the meaning of Regulation No 258/97 can also be assumed when a novel food contains traces of transgenic 30 — See Report of the OECD Workshop on the Toxicological protein which has, however, been shown to and Nutritional Testing of Novel Food, 1998; Safety aspects of genetically modified foods of plant origin, be of no concern as regards human health. Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology, 2000. A summary of It is clear, nevertheless, that establishing the development can be found in the publication by the substantial equivalence is not limited to British Royal Society, Genetically modified plants for food use and human health — an update, Policy document comparing the level of easily detectable 4/02, February 2002. components relating to nutritional physio- 31 — See Evaluation of Allergenicity of Genetically Modified Foods, Report of a joint FAO/WHO Expert Consultation logy. on Allergenicity of Foods Derived from Biotechnology, 2001. 32 — Summary: The Royal Society, p. 5 et seq. (cited in footnote 30). 3 5 — H.A. Kuiper, Food Safety Evaluation of Genetically 33 — E. Millstone et al., Beyond 'Substantial equivalence', Modified Foods as a Basis for Market Introduction, Nature 1999, Vol. 4 0 1 , p. 525. Ministerie van Economische Zaken, Den Haag (Ministry 34 — The Royal Society of Canada, Elements of Precaution: for Economic Affairs, The Hague), 1998, p. 11 (available Recommendations on the Regulation of Food Biotech- by internet, on: www.ez.nl). nology in Canada, 2 0 0 1 , p. 180 et seq. (www.rsc.ca/ 36 — See p. 4 of the proposal's statement of reasons (cited in foodbiotechnology/index/EN.html). footnote 13).

75. However, it should be borne in mind that the Recommendation, in accordance with its legal basis in Article 4(4) of Regulation No 258/97, refers to the scien- tific aspects of the information necessary to support an application for an authori- 77. Given that background, it is not sur- sation. Under the simplified procedure at prising that the Recommendation provides issue, laid down in Article 3(4) and Article 5 no standard for a clear Yes or No to the of Regulation No 258/97, however, no question of substantial equivalence. While application for the issue of an authorisation the determination of substantial equival- for placing on the market is required. ence is an important aspect of formal Rather, the requirements are addressed to authorisation, it is nevertheless not deci- companies which want to submit an appli- sive. The conditions for an authorisation to cation to the national food assessment body place novel foods on the market are, under under the application procedure laid down Article 3(1) of Regulation No 258/97, that it does not present a danger to the con- sumer, does not mislead the consumer 37— Points 14 to 16. and/or does not differ from conventional

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foods to an extent that their normal con- (f) Interpretation in the light of the mean- sumption would be nutritionally disadvan- ing and purpose of the Regulation and with tageous. For that reason, the approval of regard to the regulatory context novel foods is possible primarily for novel foods which are only partly or not at all substantially equivalent to comparable con- ventional foods. The absence of substantial equivalence does not mean that the novel food is not safe but merely that it must be assessed on the basis of its own composi- tion and properties. 38

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cally modified organisms, it merely pro- composition. The question then, of course, vided for the simplified procedure under is whether in that case a special marketing Article 3(4) and Article 5 of Regulation notification is necessary. It could perhaps No 258/97, where there is substantial be justified on the ground that unforeseen equivalence. It thereby went beyond the changes in comparison with conventional proposal by the Commission, according to foods could have occurred. Specific notifi- which — at least in the case of insignifi- cations or approvals only make sense, cant modifications — no approval what- however, where such possible changes in soever would have been required. food can be detected and ascertained under the current level of science.

83. Under the narrow interpretation, only foods could be placed on the market under 85. Nevertheless, under the broad inter- the simplified procedure which differ from pretation, the rule set out in the first indent conventional foods as the result of being of Article 3(1) must also be considered, derived from genetically modified organ- namely that the food is not to present a isms but which — as far as is known — danger for the consumer. In that regard, it do not show the slightest difference in should be borne in mind that it is not merely knowledge about the host plant which is available for consideration when 40 — Examples of corresponding processing referred to in the assessing substantial equivalence. On the literature are the distillation of oil from genetically contrary, the plant from which the intro- modified rape or the refining of sugar from genetically modified sugar beets. duced trait is derived and the protein for

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which it codes are generally also known. If 87. That circumstance may be a weakness further examination of the divergent trait of the simplified procedure, which should and of the new components of the foods be acknowledged when answering the ensures that effects on human health can be fourth question referred for a preliminary ignored and that risk to consumers can ruling. That potential disadvantage does therefore be largely excluded, that rule will not, however, preclude a broad interpre- also be taken into account when marketing tation of the concept of substantial equiv- takes place under the simplified procedure. alence. That is, inasmuch as there is no mandatory requirement for prior examin- ation by an official body of the conditions for placing on the market under the sim- plified procedure, it is not possible to prevent those conditions being disregarded, no matter how stringent they might be.

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but must nevertheless be specifically (g) Finding labelled because they are not fully equival- ent. Certain differences therefore do not exclude a determination of substantial equivalence but merely trigger a specific labelling requirement.

92. The answer to the first question referred must therefore be that Article 3(4) of Regulation N o 258/97 is to be inter- preted to mean that the foods or food ingredients referred to in Article 1(2)(b) of the Regulation are to be considered sub- stantially equivalent to existing foods and 9 0 . M o r e o v e r , in a c c o r d a n c e w i t h food ingredients and, as a result, may be Article 8(1)(b), it must be clear from the placed on the market under the simplified labelling when a novel food contains sub- procedure through a notification pursuant stances which are not present in a fully to Article 5 of the Regulation, even when equivalent food and which could have an those foods and food ingredients still con- effect on the health of particular groups of tain residues of transgenic protein but it has people. Therefore, even taking as a basis been demonstrated that those substances the narrower concept of equivalence in do not present a danger for the consumer. Article 8, it cannot be excluded that the composition of novel and conventional foods differ from one another. The novel food can even — in contrast to the equiv- alent product — contain substances which could affect the health of at least some groups of people.

B — Powers of the Member States to adopt protective measures against the plac- ing on the market of novel foods (second question referred for a preliminary ruling) 1. Submissions by the parties

94. The referring court poses the second question referred for a preliminary ruling only in the case where the answer to the first question is negative, that is to say, if novel foods cannot be considered substan- tially equivalent to existing foods inasmuch 96. Monsanto and others consider that the as they contain traces of transgenic wording of Article 12 of Regulation material. Under the solution proposed here, No 258/97 is clear. It allows Member however, that circumstance does not pre- States to act only when they have in their clude substantial equivalence, and there is possession new scientific information, thus no need to answer the second ques- which was not the case when the Decree tion. was adopted.

97. The question, therefore, is essentially whether a Member State which considers 95. Nevertheless, it appears appropriate to that the provisions concerning the simpli- consider that question in detail, for the fied procedure are invalid can adopt pro- following reasons. First, despite the solu- tective measures on the basis of the pre- tion I have proposed to the first question, it cautionary principle, even when the con- has not been determined whether the con- ditions set out in Article 12 are not met. tested food can in fact be considered That would lead to the result that a substantially equivalent. Member State could unilaterally decide

98. The Italian Government considers that Article 12, in conjunction with Article 13, provides a procedure for reviewing the approval of novel foods under which the Member State and the Commission work together. 101. Until the relevant determination" under Article 13 has been made, the Member State may suspend marketing under Article 12, provided that the con- ditions for the use of that safeguard clause are satisfied. Accordingly, the Member State may act when, as a result of new information or a reassessment of existing information, detailed grounds exist for 99. Under Article 12, a Member State may considering that the use of the novel food· temporarily suspend the marketing of a endangers human health or the environ- novel food which has been placed on the ment. market under the simplified procedure and therefore has not undergone a comprehen- sive safety assessment. As a condition, the Member State must produce scientific sub- stantiation for the absence of substantial equivalence and the resulting inapplicabil- ity of the simplified procedure. The Com- mission subsequently reviews that scientific substantiation under the procedure laid down in Article 13. 102. The Court of Justice has held 44 that such safeguard clauses give expression to 43 — Monsanto and others refer, inter alia, to Case 101/78 Granaria v Hoofdproduktschap voor Akkerbouwpro- dukten [1979] ECR 6 2 3 , paragraphs 4 and 5, and Case 44 — See the comparable provision in Article 16 of the deliberate 128/78 Commission v United Kingdom [1979] ECR 419, release directive judgment in Case C-6/99 Greenpeace paragraphs 9 and 10. France and Others [2000] ECR I-1651, paragraph 44.

(a) Preliminary observations on the justifi- cation of national measures by direct reference to the precautionary principle

104. After the Italian Government unsuc- cessfully attempted to trigger the assess- 106. The second question relates to the power of the Member States to adopt 45 — The Norwegian Government refers, in that connection, to protective measures on the basis of the point 3 of the Communication from the Commission on the precautionary principle of 2 February 2000 (COM 'precautionary principle, which is given [2000]1 final). particular expression in Article 12 of

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Regulation N o 258/97'. However, the pre- able connection between that principle and cautionary principle is not expressly men- a potential risk to objects of legal pro- tioned as a legal basis in the recitals in the tection. preamble to the Italian decree. In view of the formulation of the question referred for a preliminary ruling, the importance of the precautionary principle in that connection should briefly be considered before the provisions of the Regulation are discussed in greater detail.

46—Judgment in Case C-241/01 National Farmers' Union II [2002] ECR I-9097, paragraph 48, Case C-350/97 Mon- sees [1999| ECR I-2921, paragraph 24, and Case C-5/94 47 — See the second recital in the preamble to Regulation Hedley Lomas [1996] ECR I-25J3, paragraph 18. No 258/97, cited above in paragraph 7.

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cedure are invalid. A Community regu- (b) Powers of the Member States to adopt lation must be considered valid and binding protective measures on the basis of Regu- on the Member States unless it has been lation No 258/97 annulled or repealed by the competent Community Court. 48 The question of whether the Regulation's provisions are invalid because they do not take sufficient account of the precautionary principle must be examined in the context of the fourth question referred for a preliminary ruling. 113. Italy expressly based the Decree on Article 12 of Regulation No 258/97. 51 Before looking at that provision more closely, it is first necessary to examine what powers the second subparagraph of Article 3(4) in conjunction with Article 13 111. As the Court of Justice has estab- grants the Member States. The Italian lished, 'in the European Community, which Government particularly mentioned, as a is a community based on law, a Member basis for the measure, that it had doubts as State is bound to comply with the provi- to the substantial equivalence of foods sions of the Treaty and, in particular, to act produced from genetically modified maize. within the framework of the procedures As the Norwegian Government rightly provided for by the Treaty and by the observed, where there are doubts with applicable legislation'. 49 regard to the conditions for use of the simplified procedure, in particular as regards substantial equivalence, the second subparagraph of Article 3(4) in conjunction with Article 13 is relevant in the first instance.

115. Under the second subparagraph of 117. Apart from the question of whether it Article 3(4), the procedure laid down in is correct to consider the food as substan- Article 13 can be used to determine tially equivalent, that procedure contains whether a food satisfies the conditions of no risk assessment component. Were the use for the simplified procedure. It gives the Commission to conclude that the con- Commission the right to determine, assisted ditions of use for the simplified procedure by the Standing Committee for Foodstuffs, are not present, marketing would be sus- whether a novel food is substantially pended and an application for approval equivalent to a conventional food. In the under the authorisation procedure would case where the Standing Committee for have to be submitted. Only under that Foodstuffs does not approve the Commis- procedure could any dangers be further sion's draft decision to that effect, the assessed. Commission can, under Article 13(4), sub- mit a proposal for a decision to the Council or — if the Council fails to act — itself adopt the proposed decision.

118. The wording of the second subpara- graph of Article 3(4) does not make clear on whose initiative the procedure to review 116. The second s u b p a r a g r a p h of the conditions of use in Article 13 is to be Article 3(4) in conjunction with Article 13 instituted. The matter can be referred to the thus constitutes an instrument for review- Standing Committee for Foodstuffs under ing the applicability of the second subpara- Article 13(2), inter alia, at the request of

119. However, the following consideration suggests that Member States have the right 121. Corresponding to the Member States' to apply for a Commission decision under right of application is a duty on the part of the second subparagraph of Article 3(4) in the Commission, in the case of such an conjunction with Article 13: In contrast to application, to take all the necessary steps the simplified procedure, under the auth- to adopt a decision under the procedure orisation procedure the Member States laid down in Article 13, which the Member have wider opportunities for cooperation. State can challenge if it considers that the In particular, under Article 6(4) they may Commission's evaluation is flawed. If no present a reasoned objection to the appro- decision is adopted, it is open to the val and thereby compel an approval Member State to bring proceedings for a decision to be taken under the committee failure to act. procedure provided for in Article 13. The review under the second subparagraph of Article 3(4) in conjunction with Article 13 can be decisive in determining the use of the authorisation procedure rather than the simplified procedure. Therefore, in order for the Member State to have a compre- hensive right to take part in the auth- 122. However, it must be held that a orisation procedure, it must be able to Member State — apart from that right of request a review of the conditions of use for application — is not entitled to take meas- the simplified procedure. It can thereby ures under the provisions described above if ensure that, when an evaluation results in a it has doubts as regards the applicability of negative finding, an authorisation pro- the simplified procedure.

125. The third letter, on the other hand, 128. The Commission replied to that letter relates, inter alia, to the notifications for by letter of 10 March 2000 and asked the the placing on the market of foods derived Italian Government for scientific evidence from MON 810 maize and Bt-11 maize. In to substantiate the absence of substantial that letter, the Italian Government asks the equivalence. However, it appears that the Commission to make available to it, pur- Commission had itself not yet introduced suant to Article 5 of Regulation No 258/97, the review procedure with the participation the documentation required for an evalu- of the Standing Committee for Foodstuffs, ation of those products. Referring to after the Italian Government had clarified Article 12, it points to the possibility that its position by letter of 5 June 2000. national protective measures could be Rather, by letter of 10 July 2000, the taken on the basis of the precautionary Commission admitted the need for further principle. assessment.

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129. The Commission's conduct is all the (ii) Article 12 more surprising in that, in early 1998, it had already agreed with the Member States on a moratorium on the use of the sim- plified procedure, precisely on the basis of the problem related to the concept of substantial equivalence.

133. In contrast to the Commission pro- posal for a revised regulation on the auth- orisation of genetically modified foods, 52 Regulation No 258/97 does not provide for any systematic supervision of products placed on the market under the harmonised procedure. However, Article 12 permits the 131. However, the mere failure of the Member States to act when specific indi- Commission to act — that is, in the cations appear to call for a reassessment absence of the conditions laid down in and thereby establishes the possibility of Article 12 — does not justify unilateral product control at national level. action by Italy. Rather, the Italian Govern- ment should have brought an action for failure to act against the Commission, 52 — See, in particular, Article 6(3)(k) and Article 6(5)(b) in which has sole responsibility for initiating conjunction with Article 10 of the proposal for a regulation concerning genetically modified foods and the examination procedure. novel food ingredients (cited in footnote 13).

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134. Under Article 12(1), the Member 136. In areas where the legal provisions are State must have 'detailed grounds' for not yet harmonised, the Court of Justice concerns about potential risk. That con­ also grants the Member States, in situations dition is to be interpreted with reference to of uncertain risk, a wide degree of latitude the precautionary principle. 53 Although to protect human health by taking meas­ Article 174(2) EC expressly mentions that ures which restrict the free movement of principle as only one of the principles goods, although they must observe the underlying environmental policy, it is principle of proportionality. 56 nevertheless clear from the case-law that the principle of preventive action is also to be observed in other policy areas. 54

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assessment. For that reason, not every under Article 13. The Member State may claim or scientifically unfounded presump- maintain its temporary measures until tion of potential risk to human health or those measures come into force. It is not the environment can justify the adoption of clear what the consequences are for the national protective measures. Rather, the national measures if the Commission does risk must be adequately substantiated by not share the Member State's assessment scientific evidence. 59 and does not adopt any Community-wide measures.

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of measures is not necessary, since rapid in any event required to adopt a decision or action is generally required when new risks to refer to the Council. In principle, the are identified, particularly as regards food Italian Republic is therefore required to safety. revoke its temporary measure only once the competent Community body has taken a decision as to whether the protective meas- ure is justified and a corresponding meas- ure at Community level should accordingly be adopted, or whether the measure is not 143. However, the Member State and the justified. affected companies are for some time left in the dark about whether the Commission does not wish in fact to act, is still examin- ing the need for measures, or has already prepared measures. That uncertainty is in particular due to the fact that neither Article 12(2) nor Article 13 sets a time-limit 146. It is questionable, however, whether within which the Commission is to act. the Italian Government actually has Rather, Article 12(2) merely states that the adequate grounds for adopting the Decree. Commission is to examine the grounds 'as The Commission and the Council have soon as possible'. wide discretion when examining the com- plex scientific circumstances to be assessed under the Article 13 procedure. The Court of Justice can therefore only review the decision of the competent Community bodies to determine whether there is a 144. An examination of the steps which the manifest error of assessment or an abuse of Commission took following the notifi- discretion or whether the body has clearly cation of the Decree makes clear that it in overstepped the bounds of its compet- fact obtained an opinion from the Scientific ence. 61 It is not the task of the Court of Committee for Food. 60 However, it Justice to substitute its assessment for the refrained from submitting a proposal for assessment of the Commission, when the measures to the Standing Committee for latter has failed to act. Foodstuffs under the Article 13 procedure and had even withdrawn the proposal which it had submitted.

150. In the final analysis, however, it is not clear what conclusions can here be drawn 148. While the alleged absence of substan- on the basis of the moratorium and the tial equivalence is the main argument of the Commission's seemingly inconsistent con- Italian Government, it seems in addition to duct. Whether Italy's concerns with regard have concerns as regards the harmlessness to the products derived from genetically of the food, as can be gathered from the modified maize which are affected by the opinion of the Scientific Committee for marketing prohibition are or were scien- Food of 7 September 2000. tifically substantiated must be determined by the Commission or the Council in each individual case, under the Article 13 pro- cedure. However, an appropriate deter- mination — which is precisely what is at issue — has not yet been presented.

149. The committee did not consider those concerns to be valid. The fact that the 151. Accordingly, it must be held that the Commission and the Member States agreed Italian Government was entitled to adopt in early 1998 on a moratorium as regards temporary measures under Article 12(1) of the further use of the simplified procedure Regulation No 258/97 in that, as a result of could, however, indicate doubts as to the new information or a reassessment of absolute safety of foods which contain existing information — which certainly residues of transgenic protein and for includes the moratorium — it had valid which only substantial equivalence has grounds for assuming that the use of the been assessed. The Commission's expla- foods at issue might endanger human

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whether the Commission takes a (tacit) it should be reiterated that the competence decision concerning the approval of novel of the Member States to adopt protective foods under the simplified procedure. If measures under Article 12(1) depends that were the case, the national court then solely on the existence of new indications also asks what consequences that would that a novel food poses a risk to human have for the powers of the Member States health or the environment. under Article 12 were the approval decision to prove unlawful, for example because the determination of substantial equivalence was not correct.

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a tacit decision concerning the approval of 162. Monsanto and others claim that the food whose placing on the market is Article 5 does not breach the principles notified to it. put forward by the national court.

163. The foods for which the simplified D — Validity of Article 5 of Regulation procedure can be used do not endanger the No 258/97 (fourth question referred for a environment, since they do not contain any preliminary ruling) genetically modified organisms and there- fore cannot develop further or propagate.

166. According to the Norwegian Govern- ment, foods derived from genetically modi- fied organisms are never substantially equivalent to the corresponding traditional foods, even if they no longer contain 170. Article 3(1) of the Regulation lays genetically modified organisms as such. down clear provisions for the protection of The placing on the market of such foods health. Moreover, every novel food under the simplified procedure infringes the requires an approval, whether under the provisions concerning health and consumer simplified or the authorisation procedure. protection in Articles 95(3), 152(1), 153(1) That is in accordance with the precaution- and 174(2) EC. Article 3(4) of Regulation ary principle, which also finds expression in No 258/97 is accordingly invalid inasmuch Article 12. In addition, novel foods must be as it refers to foods within the meaning of specifically labelled in accordance with Article 1(2)(b). Article 8.

167. The European Parliament, the Coun- cil and the Commission defend the validity of the Regulation. 171. There is no doubt concerning the validity of the Regulation where the appro- val provisions are correctly applied. On the basis of the documentation which must be submitted under Article 5, the Commission is able to subject the conditions of use for the simplified procedure, in particular the existence of substantial equivalence, to 168. The European Parliament states that the question is not in fact the validity of Article 5 itself, but rather the validity of 64 — Case C-376/98 Germany v Parliament and Council [2000] Article 3(4). ECR I-8419, paragraph 78, the 'Tobacco' judgment.

174. Finally, foods approved in accordance with the rules can at any time be with- drawn from the market under the safeguard clause in Article 12 if valid grounds for risks to health come to light. 172. The Council states that a legal act is not invalid because it proves in retrospect to be inadequate. It is therefore of no importance that the Commission's pro- posal for a new regulation 65 no longer provides for a simplified procedure. There is also a simplified approval procedure for pharmaceuticals, which the Court of Justice 175. The Commission points to substan- has held to be lawful. 66 tially the same characteristics of the sim- plified procedure as does the Council, in order to demonstrate that sufficient atten- tion was given to health protection, pur- suant to Articles 153 and 174 EC. It points out, in particular, that the contested foods underwent a detailed evaluation of substan- tial equivalence by the United Kingdom food assessment body and that the Italian bodies had confirmed their harmlessness. 173. The provisions concerning the simpli- fied procedure take sufficient account of health protection. The procedure only applies to foods which pose no particular risk. It ensures, through the examination of substantial equivalence in each individual

176. The Regulation also takes account of 65 — Cited in footnote 13. the precautionary principle and the prin- 66 — Case C-368/96 Generics (UK) and Others [1998] ECR I-7967, paragraph 60 et seq., in which the Court of Justice ciple of proportionality. It should be taken reviewed the validity of a provision of Council Directive 65/65/EEC of 26 January 1965 on the approximation of into account in that regard that the Regu- provisions laid down by law, regulation or administrative lation was the first legislation in this area action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by and was guided by the scientific infor- Council Directive 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36), as regards the simplified approval mation available at the time of its adoption. procedure for generic drugs. The safeguard clause in Article 12, in

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180. Those Treaty provisions and general 182. Therefore, when drawing up Regu- legal principles cannot, however, be con- lation No 258/97, the Community legis- sidered in isolation. The situation in which lature had to reconcile the rights of com- the Regulation was adopted was primarily panies which place novel foods on the characterised by the fact that companies, market and the rights of consumers to subject to the provisions of the deliberate adequate health protection, as well as release directive and to any national rules, protection of the environment. That could place on the market foods derived required the assessment of complex scien- from genetically modified organisms with- tific relationships, which was complicated out an approval or notification. Products by the fact that the development of foods lawfully placed on the market could be derived from genetically modified organ- traded without restriction through the isms was still at an early stage in 1997 and Community, in the framework of the free that, in part, no completely certain scien- movement of goods. The point of departure tific information was yet available. is therefore freedom of action for com- panies and the free movement of goods.

183. In that case, in the light of the evalu- ation standard to be used by the Court of Justice, the following finding applies: 69

188. As has already been stated, 72 the 185. The protection of human health was protection of health is closely linked to not yet expressly mentioned as an objective the precautionary principle, which as a of c o n s u m e r p r o t e c t i o n policy in general principle of Community law has Article 129a of the EC Treaty (now, after importance beyond the field of environ- amendment, Article 153 EC) in the formu- ment policy. 73 lation of the Treaty of Maastricht, which was in force when Regulation No 258/97 was adopted.

194. First, such a control is ensured by the procedure set out in the second subpara- 191. A further condition of use is that the graph of Article 3(4) in conjunction with novel food be substantially equivalent to a Article 13. The disadvantage of that pro- comparable conventional product. In cedure is, however, that the assessment accordance with the interpretation devel- takes place only after the food has already oped above, substantial equivalence is been placed on the market by the respon- established only if it has been ascertained sible party, since Article 5 does not require that the differing characteristic which was the responsible party to delay the placing introduced does not pose any appreciable on the market until the Commission has dangers to human health. received the notification and notified the Member States. Accordingly, the food can already be on the market when the Com- mission takes action on its own initiative, or at the request of a Member State, under the second subparagraph of Article 3(4) in conjunction with Article 13.

192. For that reason, the argument by the national court, that under the simplified procedure foods could be placed on the market which have not been subject to adequate safety assessments, must be rejected, at least in a case such as the 195. Secondly, at least where the respon- present case. Moreover, it is not correct sible party does not cite generally recog- that the determination of substantial equiv- nised scientific findings, a national food alence — as it is here understood — gives assessment body carries out an assessment no information on the effects on human of substantial equivalence. In that regard, health of the traces of transgenic material Article 3(4) should be interpreted to mean found in novel foods. that the responsible party must obtain the

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200. The other Member States still have principle can influence the validity of the the opportunity to put forward their point provisions as regards the simplified pro- of view at a later stage of the procedure, by cedure in connection with the present case. requesting a review of the conditions of use for the simplified procedure. If the misgiv- ings of a Member State are accepted and it is accordingly determined that the simpli- fied procedure is not applicable, a notifi- cation procedure must be carried out, under which the Member States have further rights of participation. 204. According to the principle of propor- tionality, which is one of the general principles of Community law, actions by the Community institutions may not go beyond what is appropriate and necessary in order to achieve the objectives legit- imately pursued by the legislation in ques- tion. When there is a choice between several appropriate measures, recourse 201. Finally, it must also be taken into must be had to the least onerous, and the consideration that Article 12 grants the disadvantages caused must not be dispro- Member States the right to take protective portionate to the aims pursued. 74 measures at any time if there are valid grounds to suspect a risk to human health.

205. The national court, however, does not at all take the view that the measures adopted, namely the introduction of the 202. Accordingly, the provisions concern- simplified procedure for the placing on the ing the simplified procedure which are market of certain novel foods, go beyond relevant to the main proceedings what is necessary in order to achieve the adequately take into account the protection objective of protecting human health. On of health and the precautionary principle. the contrary, that court considers them insufficient for the purpose of attaining that objective. It argues not for a less stringent instrument, as the undertakings concerned would perhaps do with reference to the principle of proportionality, but rather for a stricter instrument.

(1) Article 3(4) of Regulation (EC) N o 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients should be interpreted to mean that foods and food ingredients within the meaning of Article 1(2)(b) of the Regulation are to be considered as substantially equivalent and may consequently be placed on the market under the simplified procedure, following a notification in accordance with Article 5 of the Regulation, when those foods and food ingredients still contain residues of transgenic protein but it has been demonstrated that those materials do not present a danger for the consumer.

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(2) A Member State may adopt temporary measures in accordance with Article 12(1) of Regulation No 258/97 provided that, as a result of new information or a reassessment of existing information, it has valid grounds for considering that the use of that food at issue endangers human health or the environment. Whether those grounds are valid or not is to be established by a Commission or Council decision pursuant to Article 12(2) in conjunction with Article 13 of the Regulation. The temporary measures may be maintained until the adoption of that decision.

(3) The Commission does not, under the simplified procedure in Article 5 of Regulation No 258/97, tacitly adopt a decision to approve a food which has been notified to it for placing on the market.

(4) The examination of the fourth question referred for a preliminary ruling has not given rise to any consideration which could vitiate the validity of the provisions concerning the simplified procedure in Article 3(4) and Article 5 of Regulation No 258/97, in so far as they — as in the present case — require the production of an opinion of a national food assessment body in order to demonstrate substantial equivalence.