EU Law Radar

Monitoring References to the Court of Justice of the European Union

Free movement of goods

Case C-282/15, Queisser Pharma – an amino acid is not necessarily mean to human health [judgment 2017, ECLI:EU:C:2017:26]

C-282/15ECLI:EU:C:2017:26judgmentCURIA ↗EUR-Lex ↗

From the archive — report by Stephen Vousden · restored via the Wayback Machine

Queisser Pharma makes a nutritional supplement with an amino acid as one of its ingredients. The company claims that the amino acid in question presents no harm to human health. Consequently, they claim that they do not need to apply to for a licence before they can make and market their nutritional supplement. However, the general approach of German law is to ban the manufacture, processing and marketing of any food supplement containing an amino acid unless companies apply for and obtain a temporary licence. The question is: is German law’s discretionary licence scheme compatible with the EU’s Regulation 178/2002 which lays down the general principles and requirements of food law?

Background
One of the products made by Queisser Pharma is a nutritional supplement. It contains iron, Vitamin C, and an amino acid known as L-Histidin. However, the use of L-Histidin in Germany is regulated by law. That is to say, before the ingredient can be used in products, companies need to obtain a licence from the relevant German authority.

In 2006, Queisser Pharma duly made their application to the German authority. However, when they did so they adopted a much more robust legal position and they informed the authority that in their view there was no need to apply for a licence because L-Histidin was an amino acid which did not represent any harm to human health.

Six years passed before the German authority decided to refuse Queisser Pharma’s licence application. It was a decision which the company appealed in 2012 but without success.

In 2013, the company lodged a further appeal at Braunschweig’s administrative court, the Verwaltungsgericht. Its main objection rested on the fact that when the relevant German legislation talked of a risk to human health, this was couched in such vague and abstract terms that the legislation could and should be thought of as breaching EU law.

More specifically, the company relied on an ECJ case that was all about a prior authorisation scheme and a legal environment that was generating a great amount of legal uncertainty for companies. Namely, in Case C-333/08, European Commission v French Republic EU:C:2010:44 the ECJ had reasoned:

89. A decision to prohibit marketing, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if the real risk alleged for public health appears sufficiently established on the basis of the latest scientific data available at the date of the adoption of such decision. In such a context, the object of the risk assessment to be carried out by the Member State is to appraise the degree of probability of harmful effects on human health from the addition of certain nutrients to foodstuffs and the seriousness of those potential effects (Commission v Denmark, paragraph 48; Case C‑24/00 Commission v France, paragraph 55; and Commission v Netherlands, paragraph 49).

The company also challenged the compatibility of the German licensing scheme with two EU Regulations. (For ease, the detailed wording of those extensive provisions is reproduced at the end of this EU Law Radar report under the heading ‘Legislative framework’.)

The first piece of EU legislation is Regulation (EC) 178/2002 that lays down the general principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety (OJ [2002] L31/1).

The relevant provisions are Articles 14 (food safety requirements), 6 (risk analysis), 7 (precautionary principle), 53 (emergency measures for intra EU food imports or third country imports) and 56 (crisis management).

Here, the primary issue is whether the German licensing framework is compatible with the EU’s food safety requirements (expressed in Article 14 of the Regulation) and EU Treaty law governing the free movement of goods. In essence, the company claims that it is disproportionate for German law to require a company to apply for an exemption licence in circumstances where a proportionate measure would only require a company to show that an ingredient does not represent a harm to human health.

In that context, the company cites German law, in particular a judicial decision from the administrative court in Magdeburg and a 2010 judgment from the German Supreme Court. If those judgments are applied in the present case, then the licensing scheme should be held to infringe (EU) law because the licenses being handed out by this particular licensing authority are of only temporary duration, even when an ingredient represents no harm to human health.

The second issue in this case involving Queisser Pharma is whether the German scheme is compatible with the requirements set out in the EU Regulation in respect of risk analysis, and the precautionary principle. The company’s main claim is that Germany’s approach is to ban amino acids irrespective of whether there is good reason to or not, something which it says is contrary to the detailed wording of the scheme set out in the EU Regulation.

The third issue arises in the event of EU law completely regulating the area of nutritional supplements and amino acids. If EU law is exhaustive, then a further matter arises in respect of a second piece of EU legislation, namely, Regulation No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ [2006] L404/26). Article 8 of that Regulation is all about ‘Substances prohibited, restricted or under Community scrutiny’. If the EU system is exhaustive, then there is no room for a national measure which deviates from that system; hence the question as to whether that interpretation of EU law is correct.

The Braunschweig Administrative Court decided to make preliminary reference.

Questions Referred
According to the Curia website, the Verwaltungsgericht Braunschweig has asked:

1. Are Articles 34, 35 and 36 of the Treaty on the Functioning of the European Union (‘the TFEU’) in conjunction with Article 14 of Regulation (EC) 178/2002 of the European Parliament and of the Council 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, […] to be interpreted as precluding national statutory provisions which prohibit the manufacture or processing and/or marketing of a food supplement with amino acids (here: L-histidine), unless a temporary derogation has been issued at the discretion of the national authority subject to specific additional factual requirements?

2. Does the scheme of Articles 14, 6, 7, 53 and 55 of Regulation (EC) No 178/2002 of the European Parliament and of the Council 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 mean that national bans on individual foods or food ingredients may only be issued under the conditions set out therein, and does this preclude a national statutory provision as set out at 1 above?

3. Is Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods […] to be interpreted as precluding a national statutory provision as set out at 1 above?

Comment
For ease, the detailed wording of the various articles of the Regulations mentioned in this litigation are reproduced below.

Legislative framework
Regulation (EC) 178/2002 that lays down the general principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety (OJ [2002] L31/1).

Article 14
Food safety requirements
1. Food shall not be placed on the market if it is unsafe.

2. Food shall be deemed to be unsafe if it is considered to be:
(a) injurious to health;
(b) unfit for human consumption.

3. In determining whether any food is unsafe, regard shall be had:
(a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and
(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

4. In determining whether any food is injurious to health, regard shall be had:
(a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations;
(b) to the probable cumulative toxic effects;
(c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers.

5. In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.

6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.

7. Food that complies with specific Community provisions governing food safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned.

8. Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe.

9. Where there are no specific Community provisions, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is marketed, such provisions being drawn up and applied without prejudice to the Treaty, in particular Articles 28 and 30 thereof.

…

Article 6
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 this 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, 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.

…

Article 7
Precautionary principle
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.

…

Article 53
Emergency measures for food and feed of Community origin or imported from a third country
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, depending on the gravity of the situation:
(a) in the case of food or feed of Community origin:
(i) suspension of the placing on the market or use of the food in question;
(ii) suspension of the placing on the market or use of the feed in question;
(iii) laying down special conditions for the food or feed in question;
(iv) any other appropriate interim measure;

(b) in the case of food or feed imported from a third country:
(i) suspension of imports of the food or feed in question from all or part of the third country concerned and, where applicable, from the third country of transit;
(ii) laying down special conditions for the food or feed in question from all or part of the third country concerned;
(iii) any other appropriate interim measure.

2. However, in emergencies, the Commission may provisionally adopt the measures referred to in paragraph 1 after consulting the Member State(s) concerned and informing the other Member States.
As soon as possible, and at most within 10 working days, the measures taken shall be confirmed, amended, revoked or extended in accordance with the procedure referred to in Article 58(2), and the reasons for the Commission’s decision shall be made public without delay.

…

CRISIS MANAGEMENT
Article 55
General plan for crisis management
1. The Commission shall draw up, in close cooperation with the Authority and the Member States, a general plan for crisis management in the field of the safety of food and feed (hereinafter referred to as “the general plan”).

2. The general plan shall specify the types of situation involving direct or indirect risks to human health deriving from food and feed which are not likely to be prevented, eliminated or reduced to an acceptable level by provisions in place or cannot adequately be managed solely by way of the application of Articles 53 and 54.
The general plan shall also specify the practical procedures necessary to manage a crisis, including the principles of transparency to be applied and a communication strategy.

The second Regulation is Regulation No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ [2006] L404/26).

Article 8
Substances prohibited, restricted or under Community scrutiny
1. The procedure provided for in this Article shall be followed where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.

2. On its own initiative or on the basis of information provided by Member States, the Commission may take a decision, following in each case an assessment of available information by the Authority and in accordance with the procedure referred to in Article 14(2), to include, if necessary, the substance or ingredient in Annex III. In particular:
(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:
(i) be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
(ii) be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
(b) if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.

3. Community provisions applicable to specified foods may provide for restrictions or prohibitions on the use of certain substances in addition to those laid down in this Regulation.

4. Food business operators, or any other interested parties, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use. The Authority shall inform without delay the Member States and the Commission of the submission and shall make the file available to them.

5. Within four years from the date a substance has been listed in Annex III, Part C, a decision shall be taken, in accordance with the procedure referred to in Article 14(2) and taking into account the opinion of the Authority on any files submitted for evaluation as mentioned in paragraph 4 of this Article, to generally allow the use of a substance listed in Annex III, Part C, or to list it in Annex III, Part A or B, as appropriate.

6. The Commission shall establish, in accordance with the procedure referred to in Article 14(2), implementing rules for the application of this Article, including rules concerning the submission referred to in paragraph 4 of this Article.

Readers interested in the law relating to Regulation 1925/2006 might be interested to know that the Administrative Division of the High Court of England and Wales has just made a preliminary reference on the issue of fortified foods and that particular Regulation, when read together with the EU Commission’s Directive 1999/21/EC on dietary foods for special medical purposes. The English court’s reference has been docketed as Case 445/15, Nutricia.

Outcome. By judgment of 19 January 2017 (ECLI:EU:C:2017:26) the Court ruled, in the words of the operative part: “Articles 6 and 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council 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 must be interpreted as precluding national legislation, such as that at issue in the main proceedings, which prohibits the manufacture, processing or marketing of any food …” The full text is available on EUR-Lex and CURIA.