Opinion of Advocate General Bobek delivered on 30 March 2017

1. Regulation No 1829/2003

4. Recital 3 of Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed states that ‘in order to protect human and animal health, food and feed consisting of, containing or produced from genetically modified organisms… should undergo a safety assessment through a Community procedure before being placed on the market within the Community’.

5. Article 1 sets out the objective of the Regulation:

‘The objective of this Regulation, in accordance with the general principles laid down in Regulation (EC) No 178/2002, is to:

1. provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food or feed, whilst ensuring the effective functioning of the internal market;

2. lay down Community procedures for the authorisation and supervision of genetically modified food and feed;

…’.

6. Pursuant to Article 34, entitled ‘emergency measures’:

‘where it is evident that products authorised by or in accordance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment, or where, in the light of an opinion of the Authority issued under Article 10 or Article 22, the need to suspend or modify urgently an authorisation arises, measures shall be taken under the procedures provided for in Articles 53 and 54 of Regulation (EC) No 178/2002’.

2. Regulation No 178/2002

7. Recital 20 of Regulation (EC) No 178/2002 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⁽⁴⁾ reads: ‘the precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food or feed. Therefore it is necessary to adopt a uniform basis throughout the Community for the use of this principle’.

8. Recital 21 states that: ‘in those specific circumstances where a risk to life or health exists but scientific uncertainty persists, the precautionary principle provides a mechanism for determining risk management measures or other actions in order to ensure the high level of health protection chosen in the Community’.

9. Article 4(2) sets out 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’. Section 1 of Chapter II of the Regulation follows immediately with Articles 6 and 7, and bears the title ‘general principles of food law’.

10. Article 6 is on risk analysis:

‘1.

In order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis except where it is not appropriate to the circumstances or the nature of the measure.

2.

Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.

3.

Risk management shall take into account the results of risk assessment, and in particular, the opinions of the Authority referred to in Article 22 [EFSA], other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) are relevant, in order to achieve the general objectives of food law established in Article 5.’

11. Article 7 is entitled ‘precautionary principle’. It states that:

‘1.

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.

2.

Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.’

12. Articles 53 and 54 regulate emergency measures for food and feed of Community origin or imported from a third country.

13. Under Article 53(1):

‘where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission, acting in accordance with the procedure provided for in Article 58(2) on its own initiative or at the request of a Member State, shall immediately adopt one or more of the following measures…’.

14. Pursuant to Article 54:

‘1.

Where a Member State officially informs the Commission of the need to take emergency measures, and where the Commission has not acted in accordance with Article 53, the Member State may adopt interim protective measures. In this event, it shall immediately inform the other Member States and the Commission.

2.

Within 10 working days, the Commission shall put the matter before the Committee set up in Article 58(1) in accordance with the procedure provided for in Article 58(2) with a view to the extension, amendment or abrogation of the national interim protective measures.

3.

The Member States may maintain its national interim protective measures until the Community measures have been adopted.’

15. Article 58(1) reads as follows:

‘The Commission shall be assisted by a Standing Committee on the Food Chain and Animal Health, hereinafter referred to as the “Committee”, composed of representatives of the Member States and chaired by the representative of the Commission. The Committee shall be organised in sections to deal with all relevant matters.’

(a) The precautionary principle as a general principle of food law

55. In general, the precautionary principle set out in Article 7 of the Regulation No 178/2002 may provide guidance for the interpretation of Article 34 of Regulation No 1829/2003. The same principle might also potentially be invoked in the context of interpretative uncertainty relating to other provisions of Regulation No 1829/2003. That follows from the systemic relationship between the two regulations, which is also expressly confirmed in Article 1 of Regulation No 1829/2003.

56. On the systemic level, as their very titles indicate, Regulation No 178/2002 lays down the general principles and requirements of food law. Regulation No 1829/2003 governs the specific area of genetically modified food and feed. Thus, unless expressly excluded, the former is potentially applicable to all sectors pertaining to food, that is to ‘any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested [by] humans’.⁽²⁷⁾ That definition logically also includes food containing, consisting of or produced from GMOs, genetically modified food, which is a specific subset within the more general category of ‘food’.⁽²⁸⁾

57. Within that structure of general regulation applicable to the entire area of food law, with its ‘general principles of food law’ (Section 1 of Chapter 2 of Regulation 178/2002), the general application of the precautionary principle amounts to ‘general applicability squared’. It is further expressly singled out as being of horizontal nature, cutting across the entire area.

58. Next, further to the overall systemic argument, applicability of the ‘general principles of food law’ is also explicitly confirmed in Article 1 of Regulation No 1829/2003. That provision clearly states that the objective of Regulation No 1829/2003 must be read in accordance with the general principles laid down in Regulation No 178/2002. It is fair to assume that ‘general principles of food law’ may be included under the heading of general principles of Regulation No 178/2002.

59. Therefore, the general principles of food law, listed in Section 1 of Chapter 2 of Regulation No 178/2002, and including the precautionary principle, are also applicable to genetically modified food.

(b) The interpretive value of the precautionary principle

60. The fact, however, that the precautionary principle as set out in Article 7 of the Regulation No 178/2002 is of horizontal or intersectional application to all food law certainly does not mean that the Member States would be entitled to act directly on its basis, independently from conditions or procedures clearly and explicitly set out in relevant secondary law.

61. Article 34 of Regulation No 1829/2003 may be seen as a concrete articulation of the precautionary principle in the specific context of genetically modified food and feed in a situation of urgency.

62. The Court has already stated, with respect to the safeguard clause contained in Article 12 of Regulation No 258/97 concerning novel foods and novel food ingredients⁽²⁹⁾ that ‘the safeguard clause must be understood as giving specific expression to the precautionary principle… [Thus] the conditions for the application of that clause must be interpreted having due regard to this principle’.⁽³⁰⁾

63. Article 34 of Regulation No 1829/2003 is, within that Regulation, functionally similar to Article 12 of Regulation No 258/97. Further to that, Article 34 can be also compared with another safeguard clause in the specific field of GMOs, namely the one contained in Directive 2001/18.⁽³¹⁾ Despite small differences in the wording, Article 23 of Directive 2001/18 and Article 34 of Regulation No 1829/2003 are comparable as they both allow Member States to adopt restrictive measures when new information or additional scientific knowledge suggests that a GMO constitutes a risk to human health or the environment.⁽³²⁾

64. The fact that Article 34 of Regulation No 1829/2003 is the concrete expression of the precautionary principle in the specific context it regulates does not preclude the ongoing interpretative value of Article 7 of Regulation No 178/2002. Indeed, as the Court stated in Monsanto, the conditions laid down by Article 34 ‘must be interpreted not only in the light of the wording of that provision, but also in the light of the purpose of Regulation No 1829/2003 and the precautionary principle, in order to ensure a high level of protection of human life and health, whilst taking care to ensure the free movement of safe and wholesome food and feed, which is an essential aspect of the internal market’.⁽³³⁾

65. Thus, the precautionary principle is relevant for the purposes of interpreting Article 34. However, that role is, in my view, limited to settling potential interpretative uncertainties or vagueness. Interpretation, however, cannot be stretched as far as to effectively seek to rewrite clearly set conditions.

66. I therefore disagree with the argument advanced by the Italian Government essentially stating that Article 7 of the Regulation No 178/2002, as an expression of the precautionary principle in the area of food law, could be used to relax the conditions set in Article 34 of Regulation No 1829/2003.

67. It should be stressed, at the outset, that a loosening of the conditions would appear to be somewhat selective. As regards the interest protected, I note that Article 34 of Regulation No 1829/2003 includes both animal health and the environment as values on the basis of which emergency measures may be taken. In contrast, Article 7 of Regulation No 178/2002 only refers to (public, that is, human) health. Thus, in terms of the nature of the protected interests, the scope of Article 34 is actually broader. Therefore, if the argument of the Italian Government were to be followed, then a number of aims arguably pursued by the emergency measures relating to animal health and the protection of environment could potentially become illegitimate.

68. I do not think that the Italian Government would like to go down that road. I understand that the primary argument of the Italian Government is rather concerned with the level of (un)certainty required to adopt emergency measures. Indeed, the threshold set by Article 7 (namely, the possibility of harmful effects is identified but scientific uncertainty persists) is clearly lower than the one in Article 34 (it is evident that the product is likely to constitute a serious risk). Article 7 of Regulation No 178/2002 could therefore be relied on to effectively lower the degree of uncertainty required to adopt emergency measures.

69. This is not possible from my point of view, for at least three reasons, aside from the systemic ones already developed. They are legality, uniformity, and the differentiated procedural context in which both provisions operate.

70. First, Article 34 of Regulation No 1829/2003 has laid down the conditions that must be met in order to adopt emergency measures. The principle of legality requires that public authorities act, both at the levels of the Union and the Member States when implementing EU law, only within the confines of what was stated, without being allowed to modify those conditions. The principle of legality becomes even more relevant when, on the basis of an arguably generous reading of EU law rules, Member States start imposing criminal sanctions.

71. Second, Article 34 is a provision of a regulation. It must therefore be interpreted uniformly, irrespective of the author of the emergency measure, of the circumstances or of the Member State concerned. That requirement of uniformity not only derives from the very nature of a regulation but also from the particular aim of Regulation No 1829/2003.

72. Generally speaking, a regulation does not leave a margin of appreciation wider than the one that follows from the permissible interpretation of its provision within the boundaries of its text. In the present situation, the conditions of an evident and serious risk are clearly set. There might certainly be doubts as to their application in a concrete case, as is the case with any indeterminate legal notion. That is, however, very different from changing those notions altogether.

73. When it comes to Regulation No 1829/2003 in particular, it is apparent that its uniform application is of great importance in fulfilling the objective of that regulation: to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumer interests in relation to genetically modified food or feed.⁽³⁴⁾

74. Finally, the textual difference in the level of (un)certainty required to trigger Article 34 of Regulation No 1829/2003, on the one hand, and Article 7 of the Regulation No 178/2002, on the other, is fully justified by the difference in procedural and systemic operation of both of these provisions.

75. As has been already outlined above in points 55-59 of this Opinion, Article 7 is applicable generally, to the entire area of food law, and also in relation to products that have never gone through an authorisation procedure. This fact translates into a medium level of (un)certainty that is required in order to justify the adoption of provisional measures: all currently available science was looked at, but uncertainty still persists.

76. By contrast, the products to which Article 34 applies are already ‘products authorised by or in accordance with this Regulation’. The authorisation procedure is the core of Regulation No 1829/2003.⁽³⁵⁾ As stated by the Court, ‘the precautionary principle… is part of such a decision-making process’.⁽³⁶⁾ No GMO for food or feed use, nor food or feed containing, consisting of or produced from GMOs shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it does not have adverse effects on human health, animal health or the environment.⁽³⁷⁾ Thus, products to which Article 34 refers have already gone through a full scientific assessment, with the involvement of the EFSA, before being placed on the market.⁽³⁸⁾

77. Accordingly, Article 34 and the higher threshold relating to the level of (un)certainty contained therein must be perceived in the context and against the compulsory authorisation procedure for GMOs. Because a full scientific review has already taken place, Article 34 may be triggered only if it is evident that there is a serious risk. Thus, in order to adopt emergency measures under Article 34, a higher level of evidence must be established, typically involving new risks not previously tested or assessed, in the framework of the authorisation procedure. It is also quite clear that Article 34 should not be used as a way to circumvent the authorisation or disregard the scientific assessment that was carried out at that stage.

78. In sum, Article 34 of Regulation No 1829/2003 represents a specific expression of the precautionary principle in the particular context of GMOs and as far as urgent measures in that context are concerned. This dual specificity justifies the differences in its articulation, in particular as far as the level of required scientific (un)certainty is concerned. Although the precautionary principle, as encapsulated in Article 7 of the Regulation No 178/2002, remains as a general principle of food law that is also applicable to the sub-area of genetically modified food, that principle does not alter the conditions clearly set out in Article 34 of Regulation No 1829/2003.