Queisser Pharma GmbH & Co. KG v Bundesrepublik Deutschland.
Date: 2017-01-19
39


As noted by the Advocate General in points 98 to 100 of his Opinion, Articles 34 to 36 TFEU do not apply to the main proceedings because, first, all the elements are confined within a single Member State (see, to that effect, judgments of 30 November 1995, Esso Española, C‑134/94, EU:C:1995:414, paragraph 13, and of 15 November 2016, Ullens de Schooten, C‑268/15, EU:C:2016:874, paragraph 47) and, second, the provisions of the LFGB, at issue in the main proceedings, do not have as object or effect disadvantaging exports vis-à-vis internal commerce (see, to that effect, judgment of 16 December 2008, Gysbrechts and Santurel Inter, C‑205/07, EU:C:2008:730, paragraph 40).
46


It must be stated, in that context, that, in the absence of harmonisation and in so far as uncertainty persists in the current state of scientific research, it is for the Member States to decide at which level they intend to ensure the protection of the health and life of persons (see, to that effect, judgments of 14 July 1983, Sandoz, 174/82, EU:C:1983:213, paragraph 16; of 23 September 2003, Commission v Denmark, C‑192/01, EU:C:2003:492, paragraph 42; and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 85).
51


The Court has held that Articles 6 and 7 of that regulation seek to achieve the general objective of a high level of protection of health (see, to that effect, judgment of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 103).
56


In that regard, a correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health of the substances or foods concerned, and, second, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research (see, to that effect, judgments of 9 September 2003, Monsanto Agricoltura Italia and Others, C‑236/01, EU:C:2003:431, paragraph 113, and of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 92).
57


Thus, where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective (judgment of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 93 and the case-law cited).
60


Such uncertainty, which is inseparable from the concept of precaution, influences the extent of the discretion of the Member State and thus has an impact on the means of applying the proportionality principle. In such circumstances, it must be accepted that a Member State may, in accordance with the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks are fully demonstrated. However, the assessment of the risk cannot be based on purely hypothetical considerations (judgment of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 91 and the case-law cited).
63


Second, once it is shown that uncertainty persists in the current state of scientific research on the harmful effects for health of certain substances, the margin of discretion of Member States relating to the choice of the level at which they intend to guarantee the protection of public health is particularly large (see, to that effect, judgment of 29 April 2010, Solgar Vitamin’s France and Others, C‑446/08, EU:C:2010:233, paragraphs 35 and 36). Consequently, as noted by the Advocate General in point 96 of his Opinion, the fact that, in circumstances such as those at issue in the main proceedings, the competent national authority has a discretion does not in itself raise issues of compatibility with Regulation No 178/2002.
66


In the context of that verification, it must be pointed out that the practical difficulties in carrying out an exhaustive assessment of the risk to health of food containing amino acids, in accordance with the case-law referred to in paragraph 56 of the present judgment, cannot justify the absence of such an exhaustive assessment prior to the adoption of a systematic and untargeted prior authorisation scheme (see, by analogy, judgment of 28 January 2010, Commission v France, C‑333/08, EU:C:2010:44, paragraph 103).