Judgment of 10 December 2015 -
BVerwG 3 C 7.14ECLI:DE:BVerwG:2015:101215U3C7.14.0
Please note that the official language of proceedings brought before the Federal Administrative Court of Germany, including its rulings, is German. This translation is based on an edited version of the original ruling. It is provided for the reader’s convenience and information only. Please note that only the German version is authoritative. Page numbers in citations have been retained from the original and may not match the pagination in the English version of the cited text. Numbers of paragraphs that have completely been omitted in the edited version will not be shown.
When citing this ruling it is recommended to indicate the court, the date of the ruling, the case number and the paragraph: BVerwG, judgment of 10 December 2015 - 3 C 7.14 - para. 16.
Use of vegetable concentrates with high nitrate content as food additives in the production of meat
Concentrates of vegetables with high nitrate content that are used in the production of meat-based products in order to stabilise the colour (so-called reddening) and to preserve the product, are to be classified as food additives within the meaning of the Regulation on Food Additives (EC) No 1333/2008.
Sources of law
Regulation (EC) No. 1333/2008 article 3 (2a), article 4 (1), article 5 Regulation (EC) No. 882/2004 article 54 Regulation (EC) No. 834/2007 article 19, article 21 Regulation (EC) No. 889/2008 article 27 Food and Feed Code LFGB, Lebensmittel- und Futtermittelgesetz section 39 Administrative Procedure Act VwVfG, Verwaltungsverfahrensgesetz section 86 (1) Code of Administrative Court Procedure VwGO, Verwaltungsgerichtsordnung section 37 (1)
Summary of the facts
The claimant - a producer of meat products - is challenging a prohibition order given under food legislation.
The claimant is a member of a farmers’ association of organic products, and markets its products under the label of said association. As a plant-based replacement for the nitrite curing salt that is conventionally used for curing, the claimant produces its products using dried vegetable mixes or vegetable juice concentrates that are made by withdrawing water from spices or vegetables with high nitrate content (hereinafter: vegetable concentrates). Also, a starter culture of micro-organisms is added, transforming the nitrate in the vegetable concentrates to nitrite. This gives the meat-based products a cured aroma and a stable pinkish-red colour (so-called reddening).
In the summer of 2010, the respondent district administration, took samples of the claimant’s products at the claimant’s facility, and had them analysed by the Regional Authority for Consumer Protection and Food Safety (Landesamt für Verbraucherschutz und Lebensmittelsicherheit). As a result of its examination, the authority informed the defendant that the meat products were not marketable, as the vegetable concentrates used during their production were not approved for use as food additives.
After a hearing, the defendant prohibited the claimant in May 2011 from producing, treating and marketing products with additives not approved for use. This prohibition applied in particular to the use of “Bio Gemüsekonzentrat” (organic vegetable concentrate) and “Bio-Gemüsemischung” (organic vegetable mix). The prohibition order was based on section 39 (2) first sentence and second sentence no. 3 of the Food and Feed Code (LFGB, Lebensmittel- und Futtermittelgesetz). In the grounds for the decision, the defendant stated that the addition of vegetable mixes with nitrate content constitutes the use of additives that are subject to food additives legislation, and that the vegetable concentrates used by the claimant do not have the required approval for use as food additives.
The claimant’s action challenging this order was unsuccessful in the lower instances.
The claimant’s appeal on points of law was rejected as well.
9 The claimant’s appeal on points of law is without merit. The challenged judgment is not based on a breach of federal law (section 137 (1) of the Code of Administrative Court Procedure (VwGO, Verwaltungsgerichtsordnung)). The Higher Administrative Court (OVG, Oberverwaltungsgericht) correctly came to the conclusion that the defendant’s prohibition order dated 16 May 2001 is lawful, and that the action for annulment therefore is not successful (section 113 (1) first sentence VwGO).
10 1. The challenged prohibition order is an administrative act with continuous effects (cf. Federal Administrative Court (BVerwG, Bundesverwaltungsgericht), judgments of 16 May 2007 - 3 C 34.06 (…) para. 19 and of 18 October 2012 - 3 C 25.11 - Rulings of the Federal Administrative Court (BVerwGE, Entscheidungen des Bundesverwaltungsgerichts) 144, 355 para. 10). This means that, in order to assess the lawfulness of this administrative act, the prevailing legal norms at the time of the decision by this Senate are decisive (BVerwG, judgment of 19 September 2013 - 3 C 15.12 - BVerwGE 148, 28 para. 9 with further references).
11 Contrary to the challenged judgment, the legal basis for the prohibition order is not section 39 (2) first sentence and second sentence no. 3 LFGB. Rather, article 54 (1), (2b) and (2h) of Regulation (EC) No. 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165 p. 1) is to be used as a legal basis, for the purposes of this case in the version last amended by Regulation (EU) No. 652/2014 of 15 May 2014 (OJ L 189 p. 1; hereinafter: Reg. No 882/2004).
12 a) Pursuant to article 54 (1) of Reg. No. 882/2004, the competent authority (cf. article 2 second sentence no. 4 of Reg. No. 882/2004), in case of non-compliance with food law, takes the required action to ensure that the operator remedies the situation (first sentence). In this context, it shall take account the operator’s past record with regard to non-compliance (second sentence). Pursuant to article 54 (2) of Reg. No. 882/2004, the authority may, inter alia, restrict or prohibit the placing on the market of foodstuffs (letter b), or take any other measures it deems appropriate (letter h). Article 2 second sentence no. 10 of Reg. No. 882/2004 defines non-compliance as any non-compliance with food law. The term food law means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at European Union or national level. It covers any stage of production, processing and distribution of food (article 2 first sentence of Reg. No. 882/2004 in conjunction with article 3 no. 1 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 <OJ L 31 p. 1>, last amended by Regulation (EU) No. 652/2014 of 15 May 2014 <OJ L 189 p. 1; hereinafter: Reg. No. 178/2002). Accordingly, the authorisation pursuant to article 54 (1) and (2) of Reg. No. 882/2004 also covers non-compliance with the legislation that is relevant here, i.e. Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354 p. 16), last amended by Regulation ((EU) 2015/1832 of 12 October 2015 (OJ L 266 p. 27; hereinafter: Reg. No. 1333/2008). In this case Reg. No 1333/2008 is not superseded by Council Regulation (EC) No. 834/2007 of 28 June 2007 on organic production and labelling of organic products (OJ L 189 p. 1; hereinafter: Reg. No. 834/2007). The challenged order is not aimed at prohibiting the claimant from marketing its meat products as organic products. However, this is the only case for which Reg. No. 834/2007 provides a legal basis (cf. article 30). The defendant’s prohibition order goes beyond this, and is aimed at a ban on the use of the vegetable concentrates in dispute here. Insofar, there is no primacy of application of Reg. No. 834/2007 (…). Marketing of food under the label “organic” within the meaning of Reg. No. 834/2007 does not affect the application of other provisions of food law (cf. article 1 (4) of Reg. No. 834/2007).
13 Also, the claimant is an operator within the meaning of article 54 (1) of Reg. No. 882/2004. These are all natural persons or legal entities responsible for ensuring that the requirements of food law are met within the food business under their control (article 2 first sentence of Reg. No. 882/2004 in conjunction with article 3 no. 3 of Reg. No. 178/2002). A food business operator is any undertaking carrying out any of the activities related to any stage of production, processing and distribution of food. This is the case for the claimant. The meat products produced by the claimant are food products within the meaning of the specified Regulations (article 2 first sentence of Reg. No. 882/2004 in conjunction with article 2 (1) Reg. No. 178/2002).
14 b) Pursuant to article 288 (2) of the Treaty on the Functioning of the European Union (TFEU), all parts of the Regulation are binding and apply directly in all Member States. Article 54 (1) and (2) of Reg. No. 882/2004 is a comprehensive and conclusive legal basis for the prohibition order in dispute here, and has primacy over the national provisions (section 39 (2) third sentence LFGB; see explanatory memorandum on section 39 (2) third sentence LFGB, Bundestag printed paper (BT-Drs., Bundestagsdrucksache) 16/8100, p. 20; Higher Administrative Court Münster, decision of 26 November 2014 - 13 B 1250/14 (…); Higher Administrative Court Mannheim, judgment of 16 June 2014 - 9 S 1273/13 (…) para. 21 et seq. with further references; Higher Administrative Court Munich, decision of 20 January 2015 - 20 CS 14.2521 - juris para. 3). This also applies in as far as the claimant was not only prohibited from marketing the meat products with the vegetable concentrates in dispute here, but also from producing and treating the meat products with these vegetable concentrates. Article 4 (1) of Reg. No. 1333/2008 regulates, inter alia, the use of food additives. As can be seen from the definition of food additives in article 3 (2a) of Reg. No. 1333/2008, this includes the process of manufacturing and treating foods. Pursuant to article 54 (2h) of Reg. No. 882/2004, the required measures pursuant to paragraph 1 may include bans on production and treatment.
15 c) The fact that the challenged prohibition order was based on section 39 (2) LFGB and - in addition to article 5 Reg. No. 1333/2008 - on the prohibition provisions in section 6 (1) no. 1a and no. 2 LFGB, does not render it unlawful. If a regulation issued in an order is lawful based on legal provisions or reasons other than those that are quoted in the order, without the nature of the regulation being changed due to the exchange of the grounds, the administrative act is not unlawful within the meaning of section 113 (1) first sentence VwGO (BVerwG, judgments of 19 August 1988 - 8 C 29.87 - BVerwGE 80, 96 <98>; of 21 November 1989 - 9 C 28.89 (…), and of 31 March 2010 - 8 C 12.09 (…)). This is the case here. The change of the legal basis and the norms used to argue that non-compliance exists do not affect the regulatory content of the prohibition order. In particular, the fact that the provisions are similar with regard to content and structure means that there are no significant changes regarding the exercising of discretion (Higher Administrative Court Münster, decision of 26 November 2014 - 13 B 1250/14 (…);Higher Administrative Court Mannheim, judgment of 16 June 2014 - 9 S 1273/13 (…) para. 25 et seq.; Administrative Court (VG, Verwaltungsgericht) Berlin, judgment of 24 March 2015 - 14 K 150.12 (…) para. 16 et seq.) The changing of the legal basis furthermore does not give rise to concerns with regard to the defendant’s competence pursuant to section 2 of the Ordinance on Competence in various Areas of Preventive Security Law (ZustVO-SOG Verordnung über Zuständigkeiten auf verschiedenen Gebieten der Gefahrenabwehr) of 18 October 1994 (Law and Ordinance Gazette Niedersachsen (GVGBl. Nds., Gesetz- und Verordnungsblatt Niedersachsen) 1994, p. 457; as amended by the Ordinance of 23 February 2015 <Nds. GVBl. 2015, p. 16>). The substantive competence pursuant to section 2 (1) no. 5 ZustVO-SOG for the tasks pursuant to section 38 (1) first sentence LFGB can easily be understood to also cover measures pursuant to article 54 of Reg. No. 882/2004 (cf. the reference to European Union law in section 39 (1) first sentence and (2) third sentence LFGB).
16 2. The contents of the order of 16 May 2011 are sufficiently specific within the meaning of section 1 (1) of the Lower Saxony Administrative Procedure Act (Niedersächsisches Verwaltungsverfahrensgesetz) in conjunction with section 37 (1) of the (Federal) Administrative Procedure Act (VwVfG,Verwaltungsverfahrensgesetz). Its objective declaratory content, taking into consideration the recipient’s viewpoint, does not give rise to doubts regarding the regulatory meaning. The claimant can unambiguously see from the operative part of the notice (Bescheid) that it is intended to prohibit from producing, treating and marketing its business foods using the contested vegetable concentrates with nitrate content. The phrase “This applies in particular to the use of “Bio Gemüsekonzentrat” (organic vegetable concentrate) and “Bio-Gemüsemischung” (organic vegetable mix).” (second sentence of the operative provisions of the official notice) does not stand against this. If this phrase is interpreted reasonably, it cannot be (mis)understood to mean that the prohibition order relates to a group of additives that is not defined conclusively. The term “in particular” is due to the regulatory technique of the operative provisions in the notice. It first generally prohibits the claimant from using non-approved additives, repeating the essential wording of section 39 (2) third sentence no. 3 LFGB and the relevant prohibition provisions (first sentence). Following this (second sentence), the order is specified in more detail, by naming the substances that are regarded as non-approved additives within the meaning of the first sentence. In the context of the grounds of the order which follow, it becomes sufficiently clear that the notice containing the prohibition order is aimed at prohibiting the claimant from using the vegetable concentrates that were the object of the examination by the food institute. The notice does not contain any statements that indicate that other substances are intended to be covered as well.
17 3. The Higher Administrative Court did not err in law when finding that the use of the vegetable concentrates in dispute here for the production of meat products constitutes a non-compliance with article 4 (1) and article 5 of Reg. No. 1333/2008, as they are to be classified as non-approved food additives.
18 a) Regulation No. 1333/2008 harmonises the use of food additives in the European Union, with a view to ensuring the effective functioning of the internal market a high level of protection of human health and a high level of consumer protection (article 1 sub-paragraph 1; recitals 1 to 4). For this purpose, the Regulation provides for Community lists of approved food additives, and the conditions of their use (article 1 subparagraph 2). It also provides for the criteria for the inclusion of food additives in Community lists (article 6 et seq.). Among these criteria are the conditions that the additive must not pose a safety concern to the health of the consumer at the dose of use proposed, that there is a reasonable technological need for its use, and that its use is of benefit to the consumer, for instance because the additive preserves the nutritional quality of the foods or enhances its continuous quality or stability (article 6 (1) and (2); recital 7). Inclusion into the Community list is carried out on the basis of a common assessment and approval procedure as set out in Regulation (EC) No. 1331/2008 of the European Parliament and of the Council of 16 December 2008 (OJ L 354 p. 1; hereinafter: Reg. No. 1331/2008). The procedure can be initiated by the European Commission or upon an application by a Member State or an interested party. The Commission has competence for the decision as to whether an additive is to be included (article 2 (1), article 3 (3) of Reg. No. 1331/2008), with the assistance of the Standing Committee on the Food Chain and Animal Health (article 14 of Reg. No. 1331/2008; article 28 (1) of Reg. No. 1333/2008).
19 On this basis, articles 4 and 5 of Reg. No. 1333/2008 provide for the requirements for the marketability of food additives. Pursuant to article 4 (1) of Reg. No. 1333/2008, only food additives included in the Community list in annex II may be placed on the market as such and used in foods under the conditions of use specified therein. Article 5 of Reg. No. 1333/2008 provides that no person shall place on the market a food additive or any food in which such a food additive is present if the use of the food additive does not comply with this Regulation. Accordingly, the defendant correctly prohibited the claimant from using the vegetable concentrates in dispute here. They constitute food additives within the definition of the term pursuant to article 3 (2a) of Reg. No. 1333/2008 (see part b) below). The substances are not approved as additives for the production of meat products (see part c) below).
20 b) Pursuant to article 3 (2a) of Reg. No. 1333/2008, a food additive is a substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods. In essence, this means the following two requirements: The substance must be added to the food for a technological purpose (positive component), and must not normally be used as a food in itself and not normally be used as a characteristic ingredient of food (negative component). The decisive factors for the assessment of the substance in dispute are its composition and its characteristics at the time the substance is added (...). Based on this, the classification of the vegetable concentrates as food additives by the Higher Administrative Court is unquestionable.
21 aa) The term “substance” as used in article 3 (2a) of Reg. No. 1333/2008 is to be interpreted in a broad sense. It covers unprocessed as well as processed substances, combined substances and mixes of substances as well as individual substances, solid substances as well as liquid or gaseous substances (...). Therefore, the classification of the vegetable concentrates as “substances” is clear. In as far as the claimant raises concerns in this respect, making reference to a legal commentary, the claimant is suffering from a misunderstanding. (…)
22 bb) The claimant uses the vegetable mix and the vegetable concentrate for technological reasons for the production of its meat products.
23 A substance is considered to be added to foods for technological reasons if it serves one or several of the purposes set out in article 6 (2), articles 7 and 8 of Reg. No. 1333/2008, as specified in detail in annex I of the Regulation in the form of a list of so-called functional classes. These functional classes are groups of additives sorted according to their technological function in foods (article 3 (2c) of Reg. No. 1333/2008), such as colours, preservatives, emulsifiers or flavour enhancers.
24 According to the findings of the Higher Administrative Court, the vegetable concentrates with nitrate content exert several of the technological functions listed in annex I. By adding the concentrate, nitrate is deposited in the treated meat, which is subsequently transformed into nitrite with the assistance of the added bacteria (starter culture). This results in a stable colour of the meat product (reddening). This process fulfils the requirements of the functional class of stabilisers pursuant to no. 24 of annex I to Reg. No. 1333/2008. According to the definition in annex I, the term “stabilisers” also covers substances that stabilise, retain or intensify an existing colour of a foodstuff. It is irrelevant that the technological effect of reddening is not caused directly by adding the vegetable concentrate, but only via a reaction product (nitrite). It suffices that the added substance is the base material for the intended technological effect. This results from the definition of the term “food additive”, according to which it suffices that the added substance or its by-products become an indirect component of the foodstuff.
25 Also, the requirements of the functional class of antioxidants are being met. This includes substances that prolong the shelf-life of foods by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes (no 4 of annex I to Reg. No. 1333/2008). The vegetable concentrates have this function, as the nitrite generated from the added nitrate counteracts the degradation of fat.
26 Therefore, it is irrelevant whether the formation of a cured flavour is to be regarded as a technological effect. The Higher Administrative Court held that this is the case, arguing that the flavour is also caused by the chemical process of transforming nitrate to nitrite. The Higher Administrative Court was correct in stating that microbiological processes do not constitute an exclusion criterion for a technological function. Whether a substance is considered to have been added for technological reasons is to be assessed exclusively by asking whether it has an effect on the foodstuff within the meaning of the technical functions not conclusively listed in annex I to Reg. No. 1333/2008. If the formation of a flavour, as is the case here, is based on a technological process rather than the aromatic or sapid properties of the added substance itself, it is therefore justified to assume that the effect has technological reasons. However, the allocation to the technological functions may give rise to doubts, as both an aromatic or sapid effect can be found in the final product. The legislator of the Regulation took into consideration that there may be overlapping, and distinguishes according to whether the focus is on the aromatic or sapid properties, with the technological effect being a mere side-effect, or whether the latter has a principal function (cf. article 3 (2a) (ii) and article 9 (1) of Reg. No. 1333/2008). However, this question does not have to be decided conclusively here. Independently of the assessment as to whether or not the cured flavour is a technological effect, the condition “for technological reasons” is already met with regard to the vegetable concentrates because they are added for purposes of reddening and anti-oxidation. These technical functions also are an essential component for the claimant, in addition to generating the cured flavour, as the Higher Administrative Court found without violating the laws of logic, and thus bindingly for these appeal proceedings on points of law (section 137 (2) VwGO). This also justifies considering the reddening as (one of the) principal effects of the vegetable concentrates, rather than a mere side-effect.
27 cc) According to the factual findings in the challenged judgment, the vegetable concentrates do not constitute substances that are normally consumed as a food in itself. The claimant’s claim of a procedural error is unsuccessful (section 137 (2) VwGO).
28 A substance is “normally” consumed as a food if such consumption is common, i.e. usual or customary (BVerwG, judgment of 01 March 2012 - 3 C 15.11 (…) para. 20). What is required is a nutritional practice that has been continuing for some time (time component), and that can be encountered with a noteworthy number of consumers (quantity component). In this context as well, the object of assessment is the added substance with the properties when used as an additive. This is already suggested by the wording of article 3 (2a) of Reg. No. 1333/2008, and is confirmed by the explanations on the scope of the Regulation in article 2 (2). According to this, the Regulation only applies to the listed substances if they are used as food additives. The provision takes into consideration multi-functional substances (...) which, depending on the context of their use, can be used for technological or other reasons. Article 2 (2) of Reg. No. 1333/2008 makes it clear that the decisive aspect for the classification of a substance is the specific use in the relevant case (...). Accordingly, the decisive aspect in this case is not the identity of the source materials of the vegetable concentrates nor the question as to whether other vegetable mixes or vegetable juice concentrates that differ from the products in dispute with regard to their source materials and composition are normally consumed as a food. The fact that the foods (vegetables) here are used in dried and concentrated form does not lead to a deviating assessment. This can be derived from the exemption clause in article 3 (2a) (ii) of Reg. No. 1333/2008 which expressly refers to such foods. As a reverse conclusion, this means that, for cases other than the exemption clause, the classification as an additive is not already excluded merely because the source substances are consumed as foods.
29 Using this as a standard, the vegetable concentrates used by the claimant do not constitute substances that are normally consumed as a food. The Higher Administrative Court stated that, and why, there are no indications for a corresponding nutritional practice. It in particular based this decision on the argument that there are no sapid or nutritional reasons for a normal consumption as a food, and that the products are not marketed as food for end consumers. Also, the Court referred to the extremely elevated nitrate content and to health considerations which make it impossible to assume that the vegetable concentrates are usually consumed as a food. The claimant failed to submit meaningful proof of the opposite, in the first instance or during the appeals proceedings. Rather, the expert involved by the claimant itself stated in his opinion that the consumption of the vegetable powder and the vegetable concentrate in an undiluted form is uncommon. In as far as the claimant submitted that the concentrates can be consumed in a processed form as vegetable juice, the Higher Administrative Court held, providing conclusive arguments, that a common nutritional practice such as this cannot be detected.
30 The claimant’s objection that there has not been the necessary clarification of facts (Aufklärungsrüge) is not successful. The Higher Administrative Court did not breach its obligation to clarify the facts (section 86 (1) VwGO). According to the minutes, the claimant did not file a formal motion to take evidence during the hearing before the court of appeal. Contrary to the submissions in the claimant’s objections, the court of appeal was not obligated to come to the conclusion that an expert opinion had to be obtained in order to determine whether or not vegetable mixes and vegetable concentrates are generally consumed as food in Germany and in other countries. According to the Higher Administrative Court’s view, as it is decisive for the required scope of the clarification of facts - which, as has been shown above, does not give rise to objections -, the only decisive aspect is whether or not vegetable concentrates with high nitrate content as used by the claimant are normally consumed as a food. The Court decided that this was not the case, with comprehensible reasons. The claimant’s submissions during the appeal proceedings, including the submitted expert opinion, do not result in any concrete indications which would cast doubt on this assessment and would have given rise to an obligation for the Higher Administrative Court to take evidence. In as far as the claimant amended its submissions in the appeal on points of law by new factual aspects, such submissions are irrelevant in this instance that only covers the appeal on points of law (BVerwG, judgment of 28 February 1984 - 9 C 981.81 (…)).
31 dd) The vegetable concentrates furthermore do not constitute substances that are normally used as a characteristic ingredient of food.
32 An ingredient is characteristic within the meaning of article 3 (2a) of Reg. No. 1333/2008 if it is a formative element of the relevant food, i.e. if it provides the food with special, typical properties (BVerwG, judgments of 25 July 2007 - 3 C 21.06 - juris para. 44 and of 01 March 2012 - 3 C 15.11(…) para. 16 (…)). In addition to this, it must normally be used as a characteristic ingredient which requires a consolidated, permanent manufacturing and nutritional practice (BVerwG, judgment of 01 March 2012 - 3 C 15.11 – see above, para. 20 et seq.). According to the findings of the previous instances, the vegetable concentrates do not constitute a characteristic component of the meat products. The supplements “Bio” and “Bioland” in the product names do not indicate such characteristic effect, as the alternative use of vegetable concentrates with nitrate content instead of the food additives E 250 and E 252 is handled in different ways by the producers of organic food. Meat products that are produced with conventional nitrite curing salt are also marketed under the label “Bio” (organic). Pursuant to article 19 (2b) and article 21 of Reg. No. 834/2007 and article 27 in conjunction with annex VIII part A of the associated implementing Commission Regulation (EC) No. 889/2008 of 05 September 2008 (OJ L 250 p. 1), sodium nitrite (E 250) and potassium nitrate (E 252) are approved for use in organic production. Therefore, the Higher Administrative Court regarded use of the vegetable concentrates instead of nitrite salt merely as characteristic for the products of the farmers’ association “Bioland”, and held that this does not suffice to assume that they are a normal and characteristic ingredient. This does not give rise to any objections within the scope of the appeal on points of law. As the effects of the vegetable concentrates (reddening, cured flavour, anti-oxidation) do not deviate from the effects traditionally generated by adding nitrite curing salt, they do not endow the meat products with any other special characteristic properties.
33 The claimant’s objection requesting clarification of the facts is unsuccessful, for the same reasons as under cc) above. According to the Higher Administrative Court’s legal assessment, which is decisive with regard to the scope of the clarification of facts, the decisive aspect is not whether or not other vegetable mixes or vegetable juice concentrates are used as a characteristic ingredient for other groups of food.
34 ee) The vegetable concentrates furthermore are not excluded from the classification as food additives pursuant to article 3 (2a (ii)) of Reg. No. 1333/2008.
35 According to this provision, “foods, whether dried or in concentrated form, including flavourings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect”, are not considered to be food additives. This provision excludes substances from the scope of the Regulation which are predominantly used for non-technological purposes, and which at the same time have a colouring effect in the final product, as a technological by-product. However, if the colouring is the principal purpose, the substance is considered to be a food additive, except if it is a substance that is normally consumed as a food in itself or normally used as a characteristic ingredient of food (cf. recital 5 and annex I no. 2 <Colours> of Regulation No. 1333/2008; similarly, the predecessor provision in article 1 (3) indent 1 of European Parliament and Council Directive No. 94/36/EC of 30 June 1994 on colours for use in foodstuffs <OJ L 237 p. 13>, which lists paprika, turmeric and saffron as examples). Accordingly, the vegetable concentrates in dispute here are not covered by the group of substances specified in article 3 (2a) (ii) of Reg. No. 1333/2008. In this context, it is not necessary to decide whether or not the vegetable concentrates are added because of their aromatic or sapid properties, within the meaning of the definition. Doubts exist in this respect, as the cured flavour - as has been stated above - is due to a technological process rather than the concentrates’ own aromatic or sapid properties. Independently of the above, the requirements of this provision are not met, as the vegetable concentrates, based on the findings of the court of appeal that are binding for the deciding Senate, do not have a secondary colouring effect. The Higher Administrative Court assumed that the intended reddening is not achieved through colouring with a colour within the meaning of functional class 2 of annex I to Reg. No. 1333/2008, but rather through a chemical colour stabilisation process within the meaning of functional class 24, which uses nitrite to transform myoglobin, the heat-sensitive red muscle pigment in meat products, to nitrosomyoglobin which is stable to heat and has a pink colour after heating. Furthermore, the technological process of colour stabilisation is not a mere secondary effect, but a principal effect of the adding of the vegetable concentrates.
36 Recital 5 of Reg. No. 1333/2008 does not lead to a deviating assessment. Sentence 3 of said recital states that substances should not be considered as food additives when they are used for the purpose of imparting flavour and/or taste or for nutritional purposes, such as salt replacers, vitamins and minerals. This objective was implemented in article 2 (2c) and (2e) as well as article 3 (2a) of Reg. No. 1333/2008, through the element of adding a substance “for technological purposes”. Pursuant to sentence 4 of recital 5 of Reg. No. 1333/2008, substances considered as foods which may be used for a technological function, such as sodium chloride or saffron for colouring should not fall within the scope of the Regulation. This is implemented in the definition of the term food additives through the exclusion criterion “not normally consumed as a food in itself and not normally used as a characteristic ingredient of food”, and also in the exclusion provision in article 3 (2a) (ii) of Reg. No. 1333/2008. Finally, sentence 5 of recital 5 of Reg. No. 1333/2008, in differentiation from the cases provided for in sentences 3 and 4, makes it clear that preparations obtained from foods and other natural source material that are intended to have a technological effect in the final food and which are obtained by selective extraction of constituents (e.g. pigments) relative to the nutritive or aromatic constituents, should be considered additives within the meaning of the Regulation. The recital is reflected in the definition of the term “colour” pursuant to functional class no. 2 in annex I to the Regulation. The statements in recital 5 therefore confirm the view that concentrates obtained from natural source material, such as spices or vegetables, and which are primarily used in a food for technological reasons are to be classified as food additives.
37 This also corresponds to the expert assessment by the Standing Committee on the Food Chain and Animal Health of 14 December 2006 (SANCO - D1(06)D/413447 (…)), according to which the adding of a spinach extract with high nitrate content for purposes of preservation and/or colour stabilisation in sausages is to be considered as use of a food additive. The Commission Working Group on “Food Additives” has reached the same conclusion with regard to vegetable stocks where the originally contained nitrate was transformed to nitrite via fermentation, and which are used for technological purposes in the production of meat-based products (cf. European Commission, Health & Consumer Directorate-General, Directorate E - Safety of the Food Chain, SANCO/E3/WD/km D (2010) (…) letter from the German Ministry for Food, Agriculture and Consumer Protection (Bundesministeriums für Ernährung, Landwirtschaft und Verbraucherschutz) of 09 June 2010 to the supreme authorities of the federal states with responsibility for food control (…). There are no indications that the statements of these bodies have been superseded by more recent pronouncements which would suggest that the assessment in the present case should differ. In as far as the claimant submitted a memorandum of a meeting of the International Federation of Organic Agriculture Movements (IFOAM) with the Directorate General for Health and Food Safety of the European Commission (DG SANCO), this constitutes a memo prepared by an IFOAM member rather than an official pronouncement by the Directorate General. Furthermore, the contents of this memorandum do not lead to the conclusion that DG SANCO generally excludes from the scope of Reg. No. 1333/2008 vegetable concentrates that are used in meat processing for technological purposes due to their high nitrate content.
38 Based on the above, there can be no reasonable doubt regarding the correct interpretation and application of article 3 (2a), including (ii) of Reg. No. 1333/2008, so that a request to the Court of Justice of the European Union (ECJ) pursuant to article 267 TFEU is not required. This also applies taking into consideration the questions proposed by the claimant for a preliminary ruling procedure. Whether the vegetable concentrates in dispute here are substances that are normally consumed as a food in itself or normally used as a characteristic ingredient of food, is an issue that relates to factual questions and has to be decided by the national trial courts. The same applies with regard to the question as to whether the concentrates are added for technological reasons, and whether the conditions in article 3 paragraph (2a) (ii) of Reg. No. 1333/2008 are met under factual aspects.
39 c) The approval as a food additive which therefore would be required has not been granted. The Community list for additives approved for use in foods (annex II to Reg. No. 1333/2008 as amended by Commission Regulation <EU> No. 1129/2011 of 11 November 2011 <OJ L 295 p. 1>) does not list the vegetable concentrates. Annex II part B (“list of all additives”) under no. 3 (“additives other than colours and sweeteners”) and part E (“approved food additives and conditions of use according to food category”) under no. 08 (“meat”), only lists potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252) as additives approved for use in meat. Pursuant to annex II part A no. 2.1 of Reg. No. 1333/2008 as amended by Commission Regulation (EU) No. 2015/647 of 24 April 2015 (OJ L 107 p. 1), they furthermore must comply with the conditions under Commission Regulation (EU) No. 231/2012 of 09 March 2012 (OJ L 83 p. 1) relating to origin, purity criteria and other specifications. The Community list does not state that vegetable concentrates are also approved instead.
40 The same applies in view of the list of additives approved for use in organic food pursuant to article 27 of Reg. No. 889/2008. Annex VIII to this Regulation lists sodium nitrite (E 250) and potassium nitrate (E 252); however, it does not list vegetable concentrates as substitute substances. Pursuant to article 27 (3) of Reg. No. 889/2008, it had to be re-examined before 31 December 2010 whether sodium nitrite and potassium nitrate should be withdrawn from the list of approved additives. The re-examination was to take account of the efforts made by Member States to find safe alternatives to nitrites/nitrates. The two substances have up to now not been withdrawn from annex VIII.
41 The claimant’s submission that its meat products have a lower nitrite content than products produced using nitrite curing salt, is irrelevant. This does not allow the conclusion that the use of vegetable concentrate as a substitute for the additives E 249 - 252 is permitted without a separate approval. According to the Higher Administrative Court’s findings, the vegetable concentrates do not have the function of a preservative pursuant to annex I no. 2 of Reg. No. 1333/2008, as the generated nitrite concentration is too low. However, when approving nitrites (E 249 and 250), the European Commission explicitly referred to their technological benefit as a preservative in meat products (cf. recital 6 of Reg. No. 1129/2011). If this benefit does not apply to the use of vegetable concentrates, it is therefore necessary to re-examine whether the conditions for the inclusion in the Community list pursuant to article 6 of Reg. No. 1333/2008 are met (cf. on the link between the technical need and health protection: ECJ, judgment of 20 March 2003 - C-3/00 [ECLI:EU:C:2003:167] - para. 82, and of 10 September 2009 - C-366/08 [ECLI:EU:C:2009:546], Adolf Darbo - para. 60). Pursuant to article 10 (1) of Reg. No. 1333/2008, this examination is exclusively subject to the procedure referred to in Reg. No. 1331/2008. Similar rules apply to the adding of substances to the list of additives approved for use in organic food (cf. article 21 (1) and (2) of Reg. No. 834/2007). (…)