Most football matches take place on the botanical commonly known as “grass.” In football stadiums, this botanical makes the playing field. The soil and grass are regularly rolled and mowed, so that football playing fields are level, to the degree that the game isn’t disturbed by unevennesses. In some sports, such as cricket, tennis and golf, the “levelness” and compactness of the grassy surface are highly critical factors.
Let’s stick to football. Above the grass hangs another playing field, where “levelness” is created by the rules of the game. These rules are identical for all teams and players. The Fédération Internationale de Football Association (FIFA) sees to it that what it calls “the Laws of the Game” are the same all over the world. Referees are trained and carefully selected to universally and consistently apply FIFA’s rules, so as to prevent discrimination of teams or individual players. The referees have full authority to enforce the Laws of the Game in connection with the match to which they have been appointed.
If referees reach different decisions in similar situations, it is not the “Laws of the Game” that cause such differences. Leaving aside bribery and prejudice, differences between decisions made in similar situations only arise when arbiters lack sufficient knowledge of the rules, when they fail to correctly apply them or when they misobserve identical situations as different. To minimize different outcomes in similar situations, the referees are assisted by 2 linesman, who watch for “off-sides” and whom the arbiters can consult in case of doubt.
The “Laws of the Game” cover all situations that can occur during a match. That’s how they create a level playing field, that leaves no room for a referee’s personal or arbitrary judgment. Which doesn’t mean that the Laws of Football have never changed or may not change over time. But the Laws of the Game are what they are. They procure a level playing field. In football, the “Laws of the Game” are seldomly blamed when a referee makes an undesirable or incorrect decision.
That is quite different in the game played by the European Member States in their attempts to defend national interests in the market for “botanicals.” Although the Laws of this Game, in casu the various European Regulations and Directives that regulate market entry or exit of “botanicals,” have been harmonized to the point where the internal market can with confidence be considered as a sufficiently regulated level playing field for all food business operators, some Member States and even the European Commission complain that the “botanical” playing field isn’t level enough.
In a previous blog, Examples of Good… or… Bad Practice, I demonstrated that the level playing field created by the European legislature is willfully disturbed by national authorities that consciously refuse to apply the Laws of the Game. To substantiate their arguments, they point at the obstacles to trade that interfere with the free movement of “botanicals” in EU’s internal market, but fail to explain that they themselves are the cause of these obstacles because they neglect and violate the Laws of the Game. One particular argument is steadily “piloted” and tested in many of the “botanical” documents and discussions. Supposedly, there are differences between the food-or-medicine “borderlines” drawn by authorities in Member States when they classify – “botanical” – products.
In its 2012 Discussion Paper on Health Claims on Botanicals used in Foods, the European Commission stated the “borderline” argument as follows: “Furthermore, since Member States have the right to classify, on a case-by-case basis, a product as food or as medicine, it is possible, as stated on several occasions by the Court of Justice of the EU, that differences exist between Member States in the classification of products. In other words, as EU law stands, it is possible that the same product is classified as a foodstuff in one Member State and as a medicinal product in another, if the national authority considers, taking account of all the characteristics of the product, that this complies with the definition of foodstuff or of medicinal product.”
In terms of football, this comes down to the FIFA stating that “since individual referees have full authority to judge, on a case-by-case basis, actions taking place during the game, it is possible that different decisions are made by different referees. In other words, as FIFA’s ‘Laws of the Game’ stand, it is possible that different decisions are made in similar situations.” As in the Commission’s statement, the crux of this statement lies in the words: “in other words.” The fact that referees (Member States) have the right to apply the “Laws of the Game” does not, “in other words,” mean or imply that different outcomes are caused by the “Laws of the Game” as they stand. Framing the situation this way absolves the referees (Member States) of any misconduct and mistake, and suggests that FIFA’s “Laws of the Game” (EU law) as they stand, have not yet exhaustively approximated all the different national rules.
The Commission’s “in other words” line of reasoning is evidently incorrect, simply because the national authorities, when classifying products, apply the very definitions laid down in EU law for the specific purpose of distinguishing, on a case-by-case basis, individual products. The Commission, which is situated in the center of Europe’s legislature, knows very well that itsdefinitions are the same in every Member State. In the European Union, all “classifiers” must apply the same legal definitions. Should different outcomes arise, the “classifiers” either misinterpreted, misapplied or misunderstood the criteria.
So, to make any sense, the Commission’s statement must really be read backwards: “…, in other words, as EU law firmly and conclusively stands, the differences that exist between Member States in the classification of products are caused by the fact that the MS’s have the right to classify products.”
By using the words “taking account of all the characteristics of the product,” the Commission not only alludes to European law, but also to European case law, implying that as EU’s case law stands, different outcomes are still possible in the food-or-medicine classification of products. In so many words, the Commission contends that in the numerous “borderline” cases that the European Court of Justice had to deal with, the Court failed to sufficiently clarify the “borderline” drawn in EU law.
As EU’s case law stands, it provides explicit criteria for resolving problems or questions concerning the food-or-medicine classification of products, especially in cases that gave rise to questions regarding the definition of “medicine by function.” The Court’s case law repetitively provides extensive and sufficiently precise explications, criteria and guidelines which exclude that national authorities, acting under the supervision of the courts, might reach different outcomes when resolving food-or-medicine disputes. When correctly applied, the Court’s case law, as it stands after many cases, precludes the arousal of heterogenous decisions in different Member States. Thereby, the Court also extinguished the need for the EU legislature to act by way of measures designed to harmonise heterogenous outcomes.
In various Judgments, the European Court of Justice has constantly held that, in establishing the food-or-medicine status of a product, no less than 6 criteria must be checked:
“For the purposes of determining whether a product falls within the definition of a medicinal product by function within the meaning of Directive 2001/83, the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular [1] its composition, [2] its pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, [3] the manner in which it is used, [4] the extent of its distribution, [5] its familiarity to consumers and [6] the risks which its use may entail.” (numeration added) [i]
Avoiding loyal execution of the Court’s instructions, authorities in several Member States tend to lay emphasis on the 2nd criterion, the pharmacological effect, to the exclusion of the other criteria, as if the pharmacological “cut-off” point would suffice to conclusively affirm the medicinal status of a product. In Case C-140/07 (Hecht-Pharma / “Red Rice”), use of the pharmacological “cut-off” point as the sole criterion in classifying a product was brought before the Court in the form of the following question:
“In its third question, […], the national court seeks to ascertain whether, following the amendment of the definition of a medicinal product by Directive 2004/27, Article 1(2)(b) of Directive 2001/83 [definition of medicine by function] must be interpreted as meaning that the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail, laid down in the case-law of the Court, are still relevant in determining whether that product comes within the definition of a medicinal product by function.” [ii]
In point 2 of its Judgment, the Court explicitly and unambiguously confirmed that in all individual cases all criteria must be checked:
“Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27, must be interpreted as meaning that the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail are still relevant to determining whether that product falls within the definition of a medicinal product by function.”
Regarding the subject at hand, the Court’s case law has reached a very high level of clarity, unambiguity and completeness. When it comes to regulating “botanicals,” EU law and EU case law jointly form a level playing field that is a hard as FIFA’s “Laws of the Game.” Under the present regulatory and judicial circumstances, obstacles to trade can only arise when national authorities fail to apply the Union’s regulations and the Court’s case law. The ensuing heterogenicity cannot and must not be solved by harmonising it, because it is the result of irregular digressions from an already harmonised situation. Instead, deviations from European law and case law deserve to be challenged before the European Court of Justice.
Still, one cannot exclude the faint possibility that, in spite of the overwhelming clarity provided by the Court, the same product is classified as a foodstuff in one Member State and as a medicinal product in another. However, such a problem can only arise in individual cases (case-by-case) and only in the unlikely event that national authorities, after having unconditionally applied all the criteria laid down in law and case law, would reach an “outlier” decision.
Moreover, in such a rare event, it remains to be seen whether the “outlier” classification would constitute an obstacle to trade in the market for “botanicals,” meaning “botanical” ingredients. After all, “borderline” issues most be solved on the basis of an evaluation of all the characteristics of an individual finished product, and not only the basis of the ingredient(s) it contains. Therefore, in the context of “obstacles” to trade, this problem is residual, negligible, and most certainly does not merit a complete overhaul of existing harmonised regulations concerning “botanicals.”
Bert Schwitters
[i] Paragraph 55 of the Judgment of the Court (First Chamber) of 15 November 2007 in Case C 319/05 (“Garlic”) is just one example of the Court’s “food-or-medicine” case law.
[ii] Point 31 in the Hecht-Pharma Judgment, Case C-140/07, 15 January 2009.
