Judgment of the Court (Fourth Chamber), 19th January 2017, in case C-282/15(Queisser Pharma GmbH & Co. KG v Bundesrepublik Deutschland)

In its request for a preliminary ruling, a German national court asks whether the requirement to obtain a temporary and discretionary derogation from the general prohibition imposed by national law before manufacturing and selling food containing, among other things, amino acids in Germany is compatible with Article 34 TFEU to Article 36 TFEU (‘Free Movement of Goods’), Regulation (EC) No 178/2002 (‘the Food Law Regulation’ – GFL) and Regulation (EC) No 1925/2006 (‘the Food Additives Regulation’).

After having deemed irrelevant Articles 34 to 36 TFEU because of the lack of transboundary elements in the present case, the ECJ focuses its decision on the scope of the precautionary principle.

Article 7 GFL defines the principle, setting a limit to the extent to which Member States may go in banning foodstuffs in the absence of EU standards and even if there is no transboundary impact. Its first paragraph provides 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 may be adopted, pending further scientific information for a more comprehensive risk assessment.

As a result, a Member State is, in principle, justified in adopting a prior authorisation scheme which prohibits the use of amino acids in foods except for when a derogation has been issued, the proviso being that scheme is based on the principle of risk analysis and the precautionary principle. As a result, the assessment of the risk cannot be based on purely hypothetical considerations. Moreover, in accordance with Article 7(2) GFL, measures adopted on the basis of Article 7(1) are to be proportionate and no more restrictive of trade than is required to achieve the high level of health protection.

Against this background, the ECJ found that the risk analysis and the resulting application of the precautionary principle appear to concern only certain amino acids, which would be insufficient to justify a prior authorisation scheme, such as that laid down in German law, which applies without distinction to all amino acids. In this connection, the absence of an exhaustive assessment prior to the adoption of a systematic and untargeted prior authorisation scheme is in breach of Article 7 GFL. Finally, temporary restrictions to the granting of those derogations, even in cases where it is established that the substance is safe, constitutes a disproportionate measure to meet the objectives pursued by the German law in question.


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