Advocate General’s Opinion - 21 July 2016, Queisser Pharma, Case C-282/15, Advocate General: Bobek

OPINION OF ADVOCATE GENERAL
BOBEK
delivered on 21 July 2016 (1)
Case C-282/15
Queisser Pharma GmbH & Co. KG
v
Bundesrepublik Deutschland
(Request for a preliminary ruling from the Verwaltungsgericht Braunschweig (Administrative Court of Brunswick, Germany))
(Food safety — Member State legislation prohibiting the manufacture and sale of food supplements containing amino acids — Possibility of discretionary derogation)




I - Introduction
1. This case concerns the procedure under German law for obtaining a derogation from the general prohibition imposed by national law on the manufacture and sale of food containing, among other things, amino acids.
2. In its request, the national court asks essentially whether the requirement to obtain a temporary and discretionary derogation before manufacturing and selling such food in Germany is compatible with Article 34 TFEU to Article 36 TFEU, Regulation (EC) No 178/2002 (‘the Food Law Regulation’) and Regulation (EC) No 1925/2006 (‘the Food Additives Regulation’).
II - Legal framework
A - EU law
1. Regulation No 178/2002: the Food Law Regulation
3. Regulation No 178/2002 (2) lays down the general principles and requirements of food law. Article 1 provides that the regulation aims at a high level of protection of human health, while ensuring effective functioning of the internal market. It also establishes ‘the means to provide a strong science base … to underpin decision-making in matters of food and feed safety’.
4. Article 4, entitled ‘Scope’, confirms that Chapter II of the regulation (which includes Articles 4 to 21) ‘relates to all stages of the production, processing and distribution of food’ and that the ‘principles laid down in Articles 5 to 10 shall form a general framework of a horizontal nature to be followed when measures are taken’.
5. Article 6, entitled ‘Risk analysis’, provides that food law shall in principle be based on risk analysis and that risk assessment ‘shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner’.
6. Article 7(1), entitled ‘Precautionary principle’, states that ‘in specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment’. Article 7(2) provides that such measures shall be proportionate.
7. Article 14 requires that food shall not be placed on the market if it is unsafe, and will be deemed to be unsafe if it is injurious to health or unfit for human consumption. Article 14(7) provides that food complying ‘with specific Community provisions governing food safety shall be deemed to be safe in so far as the aspects covered by the specific Community provisions are concerned’. Article 14(9) states that ‘where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is marketed, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof’.
8. Article 53 allows for emergency measures to be adopted by the Commission where it is evident that food or feed constitutes a serious risk that cannot be contained satisfactorily by the Member States. Article 55 gives the Commission permission to draw up a general plan for crisis management.
2. Regulation No 1925/2006: the Food Additives Regulation
9. Recital 2 of Regulation No 1925/2006 (3) provides that in the absence of specific EU rules ‘relevant national rules may apply without prejudice to the provisions of the Treaty’.
10. Article 1 sets out that the regulation relates to the addition of vitamins and minerals and of certain other substances to foods, with the purpose of ensuring the effective functioning of the internal market, whilst providing a high level of consumer protection.
11. Article 2 defines ‘other substance’ as ‘a substance other than a vitamin or a mineral that has a nutritional or physiological effect’.
12. Chapter III of the regulation is entitled ‘Addition of certain other substances’. It contains only Article 8. Article 8 provides for a procedure that ‘shall be followed’ essentially where a substance other than a vitamin or mineral is added to foods with the result that it will be ingested in higher than normal amounts or would otherwise represent a potential risk to consumers. Article 8 goes on to provide that the Commission ‘may’ take a decision to list a substance or ingredient in Annex III to the regulation.
13. Article 8(6) provides that the Commission shall establish implementing rules for the application of Article 8. These have been adopted in the form of Implementing Regulation (EU) No 307/2012. (4)
14. Article 11, entitled ‘National provisions’, provides that new national legislation on the prohibition or restriction of the addition of other substances to foods shall be notified to the Commission and subjected to a specific procedure provided for under Article 12 of the Food Additives Regulation.
B - National law
15. The following national provisions of the German Code on foodstuffs, consumer items and animal feed (Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch (‘the LFGB’)) (5) form the legal framework of the dispute under national law.
16. Paragraph 2, subparagraphs 2 and 3 of the LFGB refers to the definition of food contained in Article 2 of Regulation No 178/2002 and the definition of food additives contained in Articles 3(2)(a) and 2(2) of Regulation (EC) No 1333/2008. (6) Moreover, Paragraph 2, subparagraph 3, second sentence, assimilates with food additives:
‘1. Substances with or without nutritional value which are not usually consumed as a food on their own or as the characteristic ingredient of a food and which are added to a food for other than technological reasons during manufacturing or processing …
3. Amino acids and their derivatives …’.
17. Paragraph 4 of the LFGB provides that the provisions of the LFGB for food additives also apply for substances assimilated with them in accordance with Paragraph 2, subparagraph 3, second sentence.
18. Paragraph 6 of the LFGB states that it is forbidden:
‘1. in the manufacture or processing of foods intended to be placed on the market,
a) to use non-approved food additives, either unmixed or in mixtures with other substances,
2. to market by way of trade foodstuffs manufactured or processed in contravention of the prohibition laid down in subparagraph 1 or not conforming with a regulation issued pursuant to Paragraph 7(1) or (2) number 1 or 5 …’
19. Paragraph 54, subparagraphs 2 and 3 of the LFGB provide for the purposes of importation possible derogations from the Paragraph 6 prohibition. Such derogations are granted following a risk assessment, taking into account international scientific knowledge and eating habits in Germany. Decisions are general and apply to all importers of the relevant product. Decisions are to be adopted within a reasonable time period. Reasons must be given where this period exceeds 90 days.
20. Paragraph 68 of the LFGB provides as follows:
‘(1) In exceptional cases, derogations from the provisions of this law and the legal regulations based on this law may be issued upon application in accordance with subsections 2 and 3. …
(2) Derogations may only be authorised
1. for the manufacture, processing or marketing of specific foods …, in so far as results are expected which could be of significance to the modification or supplementation of the regulations applying to the food …, under official observation or in so far as harmonisation of the regulations with legal acts of … the European Union has not yet occurred; the legitimate interests of the individual as well as all factors which could influence the general competitive landscape of the branch of industry affected must be given appropriate consideration,
4. in other cases where, due to particular circumstances, especially the impending spoilage of food …, it appears necessary to avoid undue hardship; ...
(3) Derogations may only be issued if the facts justify the assumption that there is no risk posed to human or animal health.
(5) The derogation under subparagraph 2 may be issued for a maximum of three years. In the cases under subparagraph 2, number 1, it can, on request, be extended three times … each time for a maximum period of three years in so far as the conditions of the grant are still fulfilled.’
III - Facts, procedure and questions referred
21. Queisser Pharma GmbH & Co. KG (‘Queisser’) is established in Germany. It manufactures and sells the food supplement Doppelherz aktiv + Iron + Vitamin C + histidine + Folic Acid, which contains among other things, L-histidine (‘the Doppelherz product’). L-histidine is an amino acid.
22. In March 2006, Queisser applied to the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (Federal Office of Consumer Protection and Food Safety, ‘the BVL’) for a derogation in accordance with Paragraph 68 of the LFGB. It sought, in particular, permission to manufacture and to sell the Doppelherz product as a food supplement in Germany.
23. In November 2012, Queisser’s application was rejected. Under Paragraph 68, subparagraph 3 of the LFGB, a derogation may only be issued if the facts justify the assumption that there is no risk posed to human or animal health. The BVL did not consider that the L-histidine amino acid contained in the Doppelherz product was harmful to health. However, it did have concerns about the product due to its iron content. The application was therefore rejected, not because of the L-histidine amino acid, but because of the iron content.
24. Queisser challenged the decision by way of an administrative appeal before the BVL. It submitted scientific evidence on the safety of the iron content of the Doppelherz product. That challenge was rejected in February 2013.
25. In March 2013, Queisser appealed that rejection before the referring court. While that case was ongoing, by decision of 17 February 2015, the BVL reversed its decision and issued a derogation for a period of three years to Queisser in accordance with Paragraph 68, subparagraph 1 and Paragraph 68, subparagraph 2, number 1 of the LFGB.
26. In those circumstances, the Verwaltungsgericht Braunschweig (Administrative Court, Brunswick) stayed the proceedings and referred the following questions to the Court:
‘(1) Are Articles 34, 35 and 36 of the Treaty on the Functioning of the European Union (“the TFEU”) in conjunction with Article 14 of [Regulation No 178/2002] to be interpreted as precluding national statutory provisions which prohibit the manufacture or processing and/or marketing of a food supplement with amino acids (here: L-histidine), unless a temporary derogation has been issued at the discretion of the national authority subject to specific additional factual requirements?
(2) Does the scheme of Articles 14, 6, 7, 53 and 55 of [Regulation No 178/2002] mean that national bans on individual foods or food ingredients may only be issued under the conditions set out therein, and does this preclude a national statutory provision as set out at 1 above?
(3) Is Article 8 of [Regulation No 1925/2006] to be interpreted as precluding a national statutory provision as set out at 1 above?’
27. Written observations have been submitted by Queisser, the German Government and the Commission. Queisser and the Commission presented oral arguments at the hearing on 12 May 2015.
IV - Assessment
A - Introduction
28. The national court asks in substance if a derogation requirement for the production and sale of food supplements containing amino acids is compatible with (i) the Treaty rules on the free movement of goods, (ii) Regulation No 178/2002, and (iii) Regulation No 1925/2006. In this Opinion, I will address the national court’s questions in reverse order.
29. For the reasons I set out below, I consider that, in so far as it applies to amino acids, the national derogation regime is not covered by Regulation No 1925/2006. (7)
30. However, that regime is covered by Regulation No 178/2002, and in particular Articles 6 and 7 thereof. Those provisions require, respectively, (a) that national measures adopted in the field of food law are supported by a risk assessment based on scientific evidence, and (b) that restrictions applying the precautionary principle are proportionate. I consider that a derogation regime of the type described in the national court’s request does raise a number of questions as to its compatibility with those provisions.
31. As regards Article 34 TFEU to Article 36 TFEU, I consider that they are not applicable because the situation at hand is a purely internal one.
B - The third question
32. By its third question, the national court asks whether Article 8 of Regulation No 1925/2006 precludes a derogation regime of the type described in its order for reference.
33. Amino acids, to the extent that they have a nutritional or physiological effect and are added to food, constitute ‘other substances’ within the meaning of Article 2(2) of Regulation No 1925/2006.
34. Article 8 of Regulation No 1925/2006 lays down the procedure to be followed in order to list an ‘other substance’ in Annex III to that regulation (containing lists of ‘other substances’ for which use is prohibited or conditional or in relation to which scientific uncertainty exists). That raises the question of whether the mere fact that an amino acid is not listed in Annex III prevents Member States from imposing restrictions on its use in food.
35. I consider that the answer to that question is clearly no.
36. It is correct that, according to Article 8 of Regulation No 1925/2006, the procedure laid down in that provision ‘shall be followed’ where an ‘other substance’ is added to foods under certain conditions. (8) The use of the word ‘shall’ could be read as implying that the procedure is compulsory in all cases of prohibition or imposition of restrictions on the use of a substance.
37. However, as argued by the Commission in its written pleadings, such an interpretation is not supported by Article 11 and recital 2 of the regulation. Recital 2 of Regulation No 1925/2006 provides that where specific EU rules on ‘other substances’ have not been adopted, relevant national rules may apply. Article 11 of the regulation, entitled ‘National provisions’, provides that where a Member State seeks to enact new legislation prohibiting or restricting the use of ‘other substances’ in foods, it must notify the Commission and follow the procedure laid down in Article 12 of the regulation.
38. It therefore follows from Article 11 and recital 2 that relevant national rules adopted after the entry into force of the regulation must be notified, following a specific procedure, and can effectively be blocked by the Commission. Conversely, the regulation does not prevent the application of national rules that existed before its entry into force.
39. In the light of the above, the answer to the third question of the national court is that Article 8 of Regulation No 1925/2006 does not preclude national statutory provisions which prohibit the manufacture or processing and/or marketing of a food supplement containing amino acids, unless a temporary derogation has been issued at the discretion of the national authority.
C - Second question
40. By its second question, the national court asks whether Articles 6, 7, 14, 53 and 55 of Regulation No 178/2002 preclude a derogation regime of the type described in its order for reference.
41. According to Article 1, Regulation No 178/2002 ‘lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level’. It applies ‘to all stages of production, processing and distribution of food’. Article 4(2) provides that Articles 5 to 10 ‘form a general framework of a horizontal nature to be followed when measures are taken’. Article 4(3) states that ‘existing food law principles and procedures shall be adapted as soon as possible and by 1 January 2007 at the latest in order to comply with Articles 5 to 10’.
42. It follows from the clear wording of the above provisions that national statutory provisions such as those referred to in the national court’s first question would have to be adapted to comply with, among others, Articles 6 and 7 of Regulation No 178/2002 by 1 January 2007.
1. Applicability of Articles 14, 53, and 55 of Regulation No 178/2002
43. Before discussing in detail Articles 6 and 7 in the sections that follow below, I will first consider briefly the other provisions in Regulation No 178/2002 referred to by the national court in its second question.
44. Article 14(9) of Regulation No 178/2002 provides that, in the absence of specific Community rules, food shall be deemed to be safe if it complies with national law, without prejudice to the Treaty. The Treaty rules, in particular those on the free movement of goods to which Article 14(9) refers, are discussed below, in Section D. Aside from the Treaty, Article 14(9) otherwise simply defers to national rules. Thus, that provision does not in itself preclude a derogation regime of the type described in the national court’s request for a preliminary ruling.
45. Moreover, Article 14(9) of Regulation No 178/2002 cannot alter the conclusion on the applicability of Articles 6 and 7. Article 14(9) refers back to national rules for all of those (particular) elements not expressly covered by EU rules. It certainly cannot be understood as derogating from the principles laid down in Articles 6 and 7 of Regulation No 178/2002, which remain, being general and transversal provisions, fully applicable even in the absence of specific rules.
46. As far as the other subparagraphs of Article 14 are concerned, to the extent that no specific EU rules apply, Article 14(7) and (8) of Regulation No 178/2002, are not of direct relevance here. Article 14(1) to (6) essentially provides that food should not be marketed if it is unsafe or unfit for human consumption. Accordingly, those provisions do not in themselves preclude a derogation regime of the type described in the national court’s request.
47. As regards Articles 53 and 55 of Regulation No 178/2002, those provisions concern emergency measures and crisis management. As such, they do not in themselves preclude a derogation regime of the type described in the national court’s request.
2. General observations on Articles 6 and 7 of Regulation No 178/2002
48. Article 6 of Regulation No 178/2002 requires that risk management measures in national food law must take into account the results of a risk assessment. Risk assessment must be based on ‘available scientific evidence and undertaken in an independent, objective and transparent manner’.
49. Article 7 of Regulation No 178/2002, entitled ‘Precautionary principle’, provides that, if following a risk assessment scientific uncertainty persists, provisional risk management measures may be adopted ‘pending further scientific information for a more comprehensive risk assessment’. Any such measures must be proportionate.
50. There is an important preliminary observation to be made here about the relationship between those two provisions and the nature of the precautionary principle as expressed in Article 7. According to the clear wording of the latter provision, Member States can only base risk management measures on Article 7 after an assessment of available information has been carried out. In other words, Article 7 can only be triggered and invoked after the procedure and substance of Article 6 have been observed.
51. It follows that a derogation regime of the type described in the national court’s request cannot be based on Article 7 of Regulation No 178/2002 to the extent the prohibition on the use of unauthorised food additives under German law is not preceded by an assessment of available information, which results in scientific uncertainty as to risk. Strictly speaking, in such circumstances, Article 7 cannot be invoked to justify such a regime.
52. In the light of the foregoing, the following analysis focuses mainly on Article 6 of Regulation No 178/2002.
3. Scientific basis for decision-making
53. Article 6 of Regulation No 178/2002 expresses a basic principle of risk regulation, namely that measures must be based on science. (9) Ultimately, restrictive measures that are adopted to address identified risks may also reflect broader policy considerations. The starting point ought nevertheless to be science. (10)
54. Article 6 would therefore clearly preclude a national rule prohibiting the manufacture and marketing of a food ingredient in complete disregard of scientific evidence and without any possibility of derogation. However, that is not the type of situation the Court is faced with here. Under the system described in the order for reference, there is a prohibition but derogations can be obtained, and in this case one has been granted. Science is not disregarded; the potential problem is rather that there appears to be an initial presumption under national law that an ingredient is unsafe.
55. The issue that underlies the national court’s second question is therefore: what limitations does Regulation No 178/2002 impose on such a derogation procedure? In particular, is a prior authorisation regime acceptable at all (that is, is it ever acceptable to presume that an ingredient is unsafe)? If it is, what are the preconditions? Who must provide the information necessary for the risk assessment and who must conduct that assessment (the Member State or a market operator)? Who bears the burden of proof?
56. Before turning to these issues, I will begin with a discussion of the key judgment of the Court in Commission v France (processing aids). (11)
4. Commission v France (processing aids)
57. Few judgments of this Court specifically interpret Articles 6 and 7 of Regulation No 178/2002. (12) However, there have been several judgments in the field of the free movement of goods that have developed general principles surrounding prior authorisation procedures and risk assessment in relation to food law. (13) These principles are to a great extent transposable to the present context.
58. Of particular interest is the Court’s judgement in the case Commission v France (processing aids), (14) especially as it relates to the legality of a prior authorisation scheme (as opposed to individual authorisation decisions within such a scheme). That case concerned a law in France imposing a prior authorisation scheme on processing aids and foodstuffs manufactured using processing aids. Prior authorisation was required even where the aids or foodstuffs were lawfully manufactured in another Member State. The Commission brought an infringement action against France, arguing that the prior authorisation scheme violated the Treaty’s free movement provisions. (15)
59. The Court held that the prior authorisation scheme constituted a restriction on the free movement of goods. However, it also confirmed previous established case-law according to which prior authorisation schemes are ‘not in principle contrary to Community law provided certain conditions are fulfilled’, (16) to ensure that the schemes can be justified and are proportionate.
60. The Court laid down two such conditions. (17) First, a transparent and accessible procedure must exist for obtaining authorisation, within a reasonable time, and subject to review before national courts (‘the procedural condition’). Second, a request for authorisation may be rejected only where the substance poses a genuine threat to public health (‘the substantive condition’).
61. The French system in that case presented a number of serious procedural shortcomings. As regards the substantive condition, the Court made the following important observations.
62. First, Member States’ discretion relating to the protection of public health is particularly wide where scientific uncertainties exist. Second, Member States which invoke an exception to free movement must ‘demonstrate in each case, taking account of the results of international scientific research, that their legislation is necessary in order effectively to protect the interests referred to in [Article 36 TFEU]’. Moreover the prohibition on processing aids in that case had to ‘be based on an in-depth assessment of the risk alleged by the Member State’. Third, any measures adopted by a Member State must be proportionate. Fourth and finally, any invocation of the precautionary principle must be preceded by ‘a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research’.
63. The Court found that the French prior authorisation scheme did not comply with these substantive conditions. In particular, the Court considered that the general nature of the scheme was problematic. The Court stated that scheme should only have targeted processing aids falling into ‘dangerous or suspect categories’. (18) However, the French scheme failed to make ‘any distinction according to the various processing aids or according to the level of risk which their use might potentially pose for health’. (19) The Court went on to state that a ‘Member State cannot justify a systematic and untargeted prior authorisation scheme … by pleading the impossibility of carrying out more exhaustive prior examinations by reason of the considerable quantity of processing aids which may be used …’. (20)
64. The Court’s judgment in Commission v France (Processing aids) clearly confirms that prior authorisation schemes are not per se excluded under the free movement rules. Yet there is equally a clear aversion to indiscriminate prior authorisation schemes that lack scientific support. (21)
65. However, in my view Commission v France (Processing aids) does not answer the more detailed questions raised at point 55 of this Opinion, notably who must provide the information in the context of the risk assessment and the related burden of proof. I turn to these now.
5. Provision of information and burden of proof
66. To set the stage, there are broadly two opposing extremes that can be envisaged on these matters.
67. At one end of the spectrum, the Member State bears the burden of proof entirely. It must provide all the relevant scientific information that feeds into a comprehensive risk assessment of each individual substance. If it does not do so, the Member State cannot impose any measures in the field of food law that restrict the use or marketing of that substance, including any prior authorisation scheme (‘the liberalisation unless’ model).
68. At the other end of the spectrum, the Member State imposes a general prohibition on an ingredient or category of ingredients, without carrying out any risk assessment. By doing so the Member State effectively shifts the burden of proof to the market operator, who must provide the necessary scientific information to conduct the comprehensive risk assessment (‘the prohibition unless’ model).
69. I have strong reservations about both of these approaches. In addition I do not consider that either one is supported by case-law.
a) ‘The liberalisation unless’ model
70. As regards the first model, ‘liberalisation unless’, it is correct that a free movement logic dictates that the Member State bears the burden of justifying any restrictions on the free movement of goods. There are, however, two preliminary caveats to that broad statement. First, the statement is general, setting, in principle, the point of departure. Second, I recall that it is not Articles 34 and 36 TFEU that are being interpreted here. What is being interpreted is Article 6 (and peripherally, also Article 7) of Regulation No 178/2002, namely, provisions of secondary law in a rather sensitive area.
71. Moreover, as confirmed in Commission v France (Processing aids), case-law on free movement itself does not in principle prevent Member States from having prior authorisation requirements. Nor does it preclude Member States from requiring companies to provide information that will assist in assessing whether the Member State will allow marketing on its territory of food containing certain ingredients. (22) It was also confirmed in Commission v France (Processing aids) that the option for Member States to have recourse to a prior authorisation scheme must be genuine. It should not be rendered nugatory by conditions that in practice prevent the Member State from being able to verify the absence of a genuine risk for public health before allowing products onto its market. (23) I consider that requiring a Member State to produce a complete, iron-clad, comprehensive review of all available scientific information before allowing it to suspend marketing by way of a prior authorisation scheme would come dangerously close to doing so. Finally, I stress that the scheme outlined in this case does not involve a prohibition without derogation. It concerns a prior authorisation regime. Metaphorically speaking, the Member State is not hitting the stop button, only the pause button. What is required in terms of risk assessment and justification for the latter should logically be lower than the former. All these points tip the balance in favour of a more nuanced approach to the burden of proof.
72. A similar conclusion may be reached drawing inspiration from the judgment in the Rubinum case, (24) which in my view implicitly endorses a more nuanced approach to the burden of proof under Article 6 of Regulation No 178/2002. That case concerned an application for the annulment of a Commission regulation (25) which suspended authorisations for a certain feed additive which took the form of a microorganism. The suspension was adopted because mapping of the feed additive genome revealed genes conferring resistance to certain antibiotics that could potentially be transmitted to animals or humans. The additive was therefore considered unsafe.
73. In upholding the contested Commission regulation, the General Court dismissed the applicant’s argument that the Commission had not conducted a full risk assessment. It held that the existence of a non-hypothetical risk had been established and that the applicant had not provided any evidence or concrete argument that a (exhaustive) risk assessment would result in a finding that the concerns raised by the Commission would be outweighed by advantages of the product. (26)
74. In other words, in Rubinum, following an assessment by the public authority (in this case, the Commission) on the basis of the information it had, a risk was identified. The private operator could have challenged that finding by presenting further evidence, but failed to do so. I consider that sharing the burden of proof in this way is entirely natural in that context: each party is invited to establish and to prove its own positive statements.
75. Furthermore, there are a number of pragmatic objections to ‘the liberalisation unless’ approach. First, it is not obvious that the public authority is always best placed to pull together all the necessary scientific evidence required to conduct a comprehensive risk assessment. (27) Moreover, at least in some cases, it seems logical that the entity having the economic interest in marketing the relevant product — as opposed to society — should contribute to the information gathering exercise. (28)
76. Finally, the application in this area of ‘the liberalisation unless’ model would at best sit uneasily with, and at worst, openly contradict, the approach taken in other parallel areas. The most obvious example is the Novel Foods Regulation. (29) That regulation basically adopts ‘the prohibition unless’ model for all foods not widely consumed in the EU before 1997. It seems rather arbitrary that at that particular date the EU should flip entirely from a ‘liberalisation unless’ model to a ‘prohibition unless’ model. Not only the case-law, but also common sense supports a more nuanced approach for the pre-1997 period. (30)
b) ‘The prohibition unless’ model
77. I also have serious reservations in relation to ‘the prohibition unless’ model. I shall make just two remarks in this regard.
78. First, something akin to ‘the prohibition unless’ model is already used in a number of specific areas. As regards food supplements, Directive 2002/46 establishes an approach based on positive lists. Vitamins and minerals are prohibited from use in food supplements unless they appear on those lists. Given that the EU legislator has explicitly chosen a positive list approach in relation to those substances by adopting secondary legislation, it does not appear justified to extend ‘the prohibition unless approach’ to other substances in the absence of such legislation. (31)
79. Second, in the context of the free movement provisions, Commission v France (Processing aids), discussed above, confirms that general prohibitions on the use of substances in food, subject to possible authorisation, are problematic. Some evidence of risk in relation to each individual substance, or at least in relation to a category of substances in which the substance appears, is required.
80. However, there was no detailed discussion in that case on how the burden of proof might be shared or shift between the public authority and the private operator. Nor was there any discussion on the extent of the prima facie case that the public authority should have to establish before it suspends the use or marketing of a relevant substance pending receipt of further data. The Rubinum case discussed above at point 72 and following, would hint at a more nuanced approach.
c) The middle ground: a shared burden of proof
81. In the light of the above, I see strong arguments against both extreme positions — ‘the liberalisation unless’ and ‘the prohibition unless’ models. What then would be the reasonable middle ground?
82. The middle ground ought to take into account the need for Member States to justify the imposition of prior authorisation regimes on a substance-by-substance basis. It should also cater for the practical limitations on a Member State’s ability to carry out upfront, complete and exhaustive risk assessments for all relevant substances. More broadly, I consider that a more nuanced approach is also necessary because Regulation No 178/2002 recognises that food law generally should be based on science. It does not merely require restrictions adopted in the field of food law to be based on science.
83. Concretely, before imposing a prior authorisation regime in relation to a given substance, a Member State must in principle demonstrate, specifically in relation to that substance, that a genuine risk for public health exists. I do not consider that prior authorisation regimes in relation to categories of substances should necessarily be excluded. However, such an approach would need to be clearly justified by the Member State, for example on the basis of structural similarities between the substances belonging to the category.
84. What is called for here is a solid and convincing prima facie case, not an exhaustive review of all the available scientific information (in contrast to ‘the liberalisation unless’ approach). The prima facie case justifies the prior authorisation requirement. The prior authorisation requirement can then serve as a procedural framework to gather the information necessary to conduct a more complete assessment. Ultimately, it is the responsibility of the Member State to carry out that risk assessment, but it must be able to call upon the support of private operators to assist in the collation of data necessary for that assessment. (32)
85. From this point of view, such a burden of proof might be called a shared one. For the reasons described already in the previous sections, it comes naturally in the context of similar cases: essentially, each of the parties is called upon to establish and to prove their affirmative statements. First, the Member State must establish, on the basis of solid scientific information, that there is a credible case for doubts. Next, if that assessment is opposed and challenged, it is then for the party contradicting the science invoked or established by the Member State to provide evidence to that effect. Finally, all the thusly assembled evidence will be freely evaluated by the competent authority.
86. In accordance with existing case-law on Article 34 TFEU, a prohibition on marketing ‘can be adopted only if the alleged real risk to public health appears sufficiently established on the basis of the latest scientific data available’. (33) Where the science is not conclusive ‘but the likelihood of real harm to public health persists’, the precautionary principle as expressed under Article 7 of Regulation No 178/2002 may justify the adoption of restrictive measures. (34)
87. I consider that the above approach is consistent with the most relevant judgment in the field of the free movement of goods, Commission v France (Processing aids). Again, that case recognises that Member States may, in principle, adopt prior authorisation regimes, but firmly rejects indiscriminate and arbitrary prior authorisation schemes. Accordingly, it requires Member States to make their case for prior authorisation on a substance-by-substance basis. However, in doing so it does not impose a requirement of upfront, exhaustive risk assessment. Instead it allows for a procedural framework for information gathering, with the burden ultimately falling squarely on the Member States to conduct the assessment and establish the risk.
6. Procedural conditions
88. As mentioned above in the context of the Commission v France case (Processing aids), in addition to the substantive conditions outlined above, prior authorisation procedures must also respect certain procedural conditions. Thus, prior authorisation procedures must be accessible, transparent, conducted within a reasonable time and subject to judicial review.
89. I consider that these requirements are transposable to the context of Articles 6 and 7 of Regulation No 178/2002.
7. Application to the present case
90. It is ultimately for the national court to apply to the derogation regime at issue in the main case, the substantive and procedural conditions implied by Articles 6 and 7 of Regulation No 178/2002, and described above. However, in the light of the express questions asked by the referring court and on the basis on the factual information provided, a derogation regime of the type described in the national court’s request, in my view, raises a number of questions as to its compatibility with those provisions.
91. As regards the substantive conditions, the derogation regime appears to be rather indiscriminate. It subjects to prior authorisation food additives and substances that can be assimilated with food additives, including all amino acids. However, subject to further facts being established by the national court, it does not appear that any prima facie case of risk to public health has been made in relation to those amino acids that might justify such an indiscriminate approach.
92. Moreover, it appears that assessment of foods containing a specific amino acid is carried out in Germany on a case-by-case basis and results in individual decisions. To the extent that a prima facie case of risk did exist, but a more detailed examination of one or more individual dossiers has overturned the initial view of that amino acid, it is unclear why the presumption of risk and the prior authorisation requirement should remain in place for that amino acid. Again these are questions for the national court to consider. In conducting this examination, the national court may also take into account the fact that generally applicable derogations are considered potentially appropriate for imported goods under Paragraph 54 of the LFGB. That begs the question as to why, under Paragraph 68, generally applicable derogations are not considered appropriate but under Paragraph 54, potentially for the same substances, they are.
93. As regards the procedural conditions, I see two points of particular concern.
94. First, it is not clear that the derogation procedure takes place in a reasonable time period. According to the request for a preliminary ruling, a period of more than six years elapsed between the submission of the request by Queisser and the initial decision of the competent national authority. At first sight this period appears excessive in and of itself. That view is further supported by the procedure laid down in Paragraph 54 of the LFGB, which foresees that reasons must be given where a decision takes more than 90 days to adopt. Again, it is for the national court to decide on the reasonableness of the absence of any deadline for adopting a decision generally, under Paragraph 68 of the LFGB and the reasonableness of the time taken in Queisser’s case specifically.
95. Second, under Paragraph 68(5) of the LFGB, derogations are granted on a temporary basis (three years) and can be renewed three times only. It is not clear from the file what happens after that period has elapsed. If the answer is that a definitive decision is taken to either allow or prohibit, (35) I do not consider that the temporary nature of the derogations in itself raises problems of compatibility with Articles 6 and 7 of Regulation No 178/2002 and the procedural conditions those provisions imply in the context of a prior authorisation scheme. However, from the point of view of the substantive conditions imposed by those provisions, the temporary nature of the derogations must be justified. In that regard, from the moment absence of risk is firmly established, recourse to temporary derogations should, in principle, be excluded. (36)
96. Finally, as regards the requirement for judicial review, competent national authorities must be allowed a broad discretion in an area such as that involved in the present case, in which it is called upon to undertake complex assessments. Consequently, the legality of a measure adopted in that area can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institution is seeking to pursue. (37) Therefore, the fact that a margin of discretion is left to the competent national authority does not in itself raise issues of compatibility with Regulation No 178/2002.
97. In the light of the above, I propose that the Court answers the second question of the national court as follows: Articles 14, 53 and 55 of Regulation No 178/2002 do not preclude a derogation regime of the type described in the request for a preliminary ruling. Articles 6 and 7 of Regulation No 178/2002 must be interpreted as precluding national statutory provisions which prohibit the manufacture or processing and/or marketing of a food supplement with amino acids, unless a temporary derogation has been issued at the discretion of the national authority, subject to specific additional factual requirements, to the extent that those restrictions apply to ingredients or categories of ingredients without any prima facie risk having been established by the Member State in relation to those ingredients or categories of ingredients. To the extent that such national provisions are justified on the basis of a prima facie risk, Articles 6 and 7 of Regulation No 178/2002 require that the procedure for obtaining a derogation from the general prohibition be accessible, transparent and completed within a reasonable time and that resulting decisions be subject to judicial review.
D - Articles 34 to 36 TFEU
98. Queisser is established in Germany and manufactures the Doppelherz product in Germany for the German market. As a result, the request for a preliminary ruling concerns a purely internal situation not linked to the importation of goods in intra-EU trade. (38) I also note that the LFGB contains a specific provision — Paragraph 54 — relating to importation from other EU Member States.
99. It follows that Article 34 TFEU does not apply in this case. That conclusion is unchanged by the fact that Article 14 of Regulation No 178/2002 explicitly refers to Article 34 TFEU. Absent any cross-border element, Article 34 TFEU does not add anything new to the analysis.
100. As pointed out by the German Government, nothing in the LFGB specifically aims at disadvantaging exports vis-à-vis internal commerce. (39) As a result, Article 35 TFEU does not apply in this case either.
101. In the light of the foregoing, I propose that the Court answers the first question of the national court such that Articles 34, 35 and 36 TFEU in conjunction with Article 14 of Regulation No 178/2002 do not preclude a derogation regime of the type described in the request for a preliminary ruling.
V - Conclusion
102. I propose to the Court that it answers the questions referred to it by the Verwaltungsgericht Braunschweig (Administrative Court, Brunswick) as follows:
Question 1
Articles 34, 35 and 36 TFEU in conjunction with Article 14 of Regulation No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety do not preclude national provisions which prohibit the manufacture or processing and/or marketing of a food supplement containing amino acids, unless a temporary derogation has been issued at the discretion of the national authority, subject to specific additional factual requirements.
Question 2
Articles 14, 53 and 55 of Regulation No 178/2002 do not preclude a derogation regime of the type described in the request for a preliminary ruling. Articles 6 and 7 of Regulation No 178/2002 must be interpreted as precluding national provisions which prohibit the manufacture or processing and/or marketing of a food supplement with amino acids, unless a temporary derogation has been issued at the discretion of the national authority, subject to specific additional factual requirements, to the extent that those restrictions apply to ingredients or categories of ingredients without any prima facie risk having been established by the Member State in relation to those ingredients or categories of ingredients. To the extent that such national provisions are justified on the basis of a prima facie risk, Articles 6 and 7 of Regulation No 178/2002 require that the procedure for obtaining a derogation from the general prohibition be accessible, transparent and completed within a reasonable time and that resulting decisions be subject to judicial review.
Question 3
Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods does not preclude national statutory provisions which prohibit the manufacture or processing and/or marketing of a food supplement containing amino acids, unless a temporary derogation has been issued at the discretion of the national authority.
1 - Original language: English.
2 - Regulation of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1).
3 - Regulation of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ 2006, L 404, p. 26).
4 - Commission Implementing Regulation of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (OJ 2012 L 102, p. 2).
5 - Of 3 June 2013 (BGBl. I, p. 1426), last amended by the Law of 5 December 2014 (BGBl. I, p. 1975).
6 - Regulation of the European Parliament and of the Council of 16 December 2008 on food additives (OJ 2008 L 354, p. 16).
7 - I add that in my point of view, in the present case, the national derogation regime is not covered either by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ 2008 L 354, p. 16) or Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51). According to Article 3(2)(a)(ix), Regulation No 1333/2008 does not apply to amino acids not having a technological function. Article 11(2) of Directive 2002/46 provides that, absent implementing acts in relation to ‘other substances’ (which include amino acids), national rules can apply without prejudice to the Treaty. No such relevant acts have been adopted. Thus, both legal instruments are inapplicable to the present case.
8 - Essentially where a potential risk is created, in particular due to ingestion of abnormally high amounts of the ‘other substance’.
9 - Independently of the adoption of Regulation No 178/2002, it was already established by case-law that restrictions on the free movement of food or food ingredients based on public health concerns arising from their constituents could only be found proportionate if they had as their foundation a review of the relevant science — see, for example, judgments of 5 February 2004 in Greenham and Abel (C-95/01, EU:C:2004:71, paragraph 39 et seq.), and 23 September 2003 in Commission v Denmark (C-192/01, EU:C:2003:492, paragraph 40 et seq.).
10 - The same idea is also central to Article 7 of Regulation No 178/2002. In case of scientific uncertainty, risk management measures may be adopted, but that is a temporary fix pending further scientific information.
11 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44).
12 - Judgment of 9 September 2011 in France v Commission (T-257/07, EU:T:2011:444) (this judgment relates to the compatibility with the precautionary principle of a relaxation of the restrictive measures adopted to combat spongiform encephalopathies; upheld on appeal in the judgment of 11 July 2013 in France v Commission (C-601/11 P, EU:C:2013:465)); judgment of 21 May 2015 in Rubinum v Commission (T-201/13, EU:T:2015:311) (discussed further below from point 72 of this Opinion, this judgment relates to the compatibility with Article 6 of a Commission implementing regulation). Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44) which is discussed below, mentions Article 6, but is an infringement action based purely on what is now Article 34 TFEU.
13 - See, for example, judgments of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44); 5 February 2004 in Greenham and Abel (C-95/01, EU:C:2004:71); 2 December 2004 in Commission v Netherlands (C-41/02, EU:C:2004:762); 23 September 2003 in Commission v Denmark (C-192/01, EU:C:2003:492); and 14 July 1983 in Sandoz (174/82, EU:C:1983:213).
14 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44). Processing aids are used to assist the food manufacturing process in a number of ways (for example, as catalysts or agents for removing impurities).
15 - The judgment makes reference to Regulation No 178/2002, but violation of that regulation is not argued by the Commission as grounds for the infringement.
16 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44, paragraph 80). See also judgments of 23 September 2003 in Commission v Denmark (C-192/01, EU:C:2003:492, paragraph 44), and 5 March 2009 in Commission v Spain (C-88/07, EU:C:2009:123, paragraph 87).
17 - Building on established case-law beginning with the judgment of 14 July 1983 in Sandoz (174/82, EU:C:1983:213).
18 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44, paragraph 95).
19 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44, paragraph 100).
20 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44, paragraph 103).
21 - See also in relation to the need for a more case-by-case approach, judgment of 5 March 2009 in Commission v Spain (C-88/07, EU:C:2009:123, paragraphs 92 and 93).
22 - See, for example, judgment of 14 July 1983 in Sandoz (174/82, EU:C:1983:213, paragraph 23).
23 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44, paragraphs 108 and 109).
24 - Judgment of 21 May 2015 in Rubinum v Commission (T-201/13, EU:T:2015:311).
25 - Although this case concerns a challenge to an EU as opposed to a national measure, the alleged violation was also of Article 6 of Regulation No 178/2002. There is no reason to interpret that provision differently in those two types of cases: it should not matter whether the contested measure was adopted by an EU or by a Member State institution. Both are obliged to apply Article 6 and ought to do so in the same way.
26 - Judgment of 21 May 2015 in Rubinum v Commission (T-201/13, EU:T:2015:311, paragraphs 90 and 91).
27 - In terms of resources (financial and human), knowledge of the relevant products and access to relevant data/scientific information.
28 - See for example, Szajkowska, A., ‘The Impact of the Definition of the Precautionary Principle in EU Food Law’, CML Rev. 47, 2010, pp. 173 to 196 at p. 192.
29 - Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ 1997 L 43, p. 1), to be repealed and replaced by Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ 2015 L 327, p. 1).
30 - Of course, there are excellent reasons to think hard before questioning the safety of food ingredients that have formed part of the human diet for millennia. However, it is also the case that many food ingredients concerned are relatively recent and simply do not occur naturally in the form or level of concentration in which they are placed on the market. An extreme approach to the interpretation of legislation that is intended to be applied to such vastly different factual circumstances is unlikely to have a happy ending.
31 - The intention of the EU legislator was also to create such positive lists in relation to other substances, including amino acids, but that has not yet happened.
32 - See above, judgment of 14 July 1983 in Sandoz (174/82, EU:C:1983:213).
33 - Judgment of 28 January 2010 in Commission v France, (C-333/08, EU:C:2010:44, paragraph 89).
34 - Judgment of 28 January 2010 in Commission v France (C-333/08, EU:C:2010:44, paragraph 93).
35 - If prohibition is the only possible outcome, this would, in principle, be incompatible with the substantive conditions attaching to the prior authorisation scheme, since it would be independent of the risk assessment.
36 - Furthermore, the fact that temporary restrictions are admitted only where uncertainty as to risk persist finds clear textual support in Article 7 of Regulation No 178/2002.
37 - See, in that sense, judgment of 12 July 2005 in Alliance for Natural Health and Others (C-154/04 and C-155/04, EU:C:2005:449, paragraph 52).
38 - See, for example, judgment of 5 December 2000 in Guimont (C-448/98, EU:C:2000:663, paragraph 21).
39 - Judgments of 8 November 1979 in Groenveld (15/79, EU:C:1979:253, paragraph 7), and 16 December 2008 in Gysbrechts and Santurel Inter (C-205/07, EU:C:2008:730, paragraph 40).
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