CELEX:62015CJ0282: Judgment of the Court (Fourth Chamber) of 19 January 2017.#Queisser Pharma GmbH & Co. KG v Bundesrepublik Deutschland.#Request for a preliminary ruling from the Verwaltungsgericht Braunschweig.#Reference for a preliminary ruling — Free movement of goods — Articles 34 TFEU to 36 TFEU — Purely domestic situation — Food safety — Regulation (EC) No 178/2002 — Article 6 — Principle of risk analysis — Article 7 — Precautionary principle — Regulation (EC) No 1925/2006 — Member State legislation prohibiting the manufacture and sale of food supplements containing amino acids — Situation in which a temporary derogation to that prohibition is at the discretion of the national authority.#Case C-282/15.

Case C‑282/15 – Queisser Pharma GmbH & Co. KG v Bundesrepublik Deutschland

Request for a preliminary ruling from the Verwaltungsgericht Braunschweig (Administrative Court, Brunswick, Germany) – 27 May 2015, received 11 June 2015.

Court composition

• President: T. von DANWITZ
• Judges: E. Juhász, C. Vajda, K. Jürimäe, C. Lycourgos (Rapporteur)
• Advocate General: M. Bobek
• Registrar: K. Malacek

Observations submitted on behalf of

• Queisser Pharma GmbH & Co. KG (A. Meisterernst, Rechtsanwalt)
• German Government (T. Henze, B. Beutler)
• European Commission (S. Grünheid, E. Manhaeve)

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Judgment

1. The request concerns the interpretation of:

   • Regulation (EC) No 178/2002 (General principles and requirements of food law) – see OJ 2002 L 31, p. 1
   • Regulation (EC) No 1925/2006 (Addition of vitamins, minerals and certain other substances to foods) – see OJ 2006 L 404, p. 26
   • as amended by Regulation (EC) No 108/2008 – see OJ 2008 L 39, p. 11
   • Articles 34 to 36 TFEU.

2. The dispute concerns an application for a derogation from the German prohibition on the manufacture and marketing of a food supplement containing the amino acid L‑histidine.

Legal context – Regulation No 178/2002

3. Article 1 defines the scope of the regulation as guaranteeing a high level of protection of human health and consumers’ interests in relation to food.

4. Article 3(11) defines “risk assessment” as a scientifically based process consisting of hazard identification, hazard characterisation, exposure assessment and risk characterisation.

5. Article 4 sets out the general framework of principles (Articles 5‑10) to be followed when measures are taken.

6. Article 6 (Risk analysis) and Article 7 (Precautionary principle) require risk assessment based on scientific evidence and allow provisional measures when scientific uncertainty persists.

7. Article 14 states that food shall not be placed on the market if it is unsafe (injurious to health or unfit for human consumption).

Legal context – Regulation No 1925/2006

10. Recitals 1‑2 define “other substances” (including amino acids) and the need for EU‑wide harmonisation, but note that in the absence of specific EU rules national provisions may still apply.

11. Article 2 provides definitions, including “other substance”.

12. Article 8 sets out the procedure for prohibiting or restricting “other substances”.

German law (LFGB)

14. The German Food and Feed Code (LFGB) aims to protect human health and implements EU food‑law provisions.

15‑21. Various paragraphs of the LFGB outline the scope, definitions, prohibitions, and the possibility for the Federal Ministry to grant derogations for up to three years, renewable three times.

Questions referred for a preliminary ruling

1. Do Articles 34‑36 TFEU together with Article 14 of Regulation 178/2002 preclude national provisions that prohibit the manufacture or marketing of a food supplement containing amino acids unless a temporary derogation has been issued?
2. Does the scheme of Articles 14, 6, 7, 53 and 55 of Regulation 178/2002 preclude such national bans?
3. Is Article 8 of Regulation 1925/2006 to be interpreted as precluding the national provision?

Court’s reasoning (selected points)

• Articles 34‑36 TFEU do not apply because the dispute is confined to a single Member State and the national measures do not affect export.
• Regulation 1925/2006 does not preclude national rules on amino acids, as there is no specific EU prohibition.
• Articles 6 and 7 of Regulation 178/2002 require that any national prohibition be based on a risk analysis covering the specific substances concerned and that the precautionary principle be applied proportionately.
• The LFGB’s blanket prohibition of all amino acids, without distinction, is not justified by a risk analysis limited to certain amino acids.
• The limitation of derogations to a maximum of three years (renewable) is a disproportionate measure when safety has been established.

Conclusion

Articles 6 and 7 of Regulation (EC) No 178/2002 must be interpreted as precluding national legislation that:

• prohibits the manufacture, processing or marketing of any food supplement containing amino acids unless a derogation has been issued, and
• bases the prohibition on a risk analysis that concerns only certain amino acids, or
• limits the duration of derogations to a specific period even where safety is established.

Costs – The decision on costs is for the national court; costs incurred by the Court (other than those of the parties) are not recoverable.

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Language of the case: German.