Colouring Foods: Product Status and Labelling Issues in the EU

Colouring Foods:

Product Status and Labelling Issues in the EU Dr. Andreas Reinhart, Dr. Markus Kraus and Paul Collins

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Colouring Foods: Product Status and Labelling Issues in the EU Andreas Reinhart, Markus Kraus and Paul Collins*

I. Introduction Foods with their inherent colouring properties, usually referred to as “colouring foods”, are a very important alternative to the traditional (additive) food colours for the food industry. Their escalating importance to the food industry is driven by an increasing understanding and awareness on behalf of the consumer with their resultant desire to have food products coloured in the most natural, healthy and clean-label way possible. Colouring foods very effectively fulfil this growing consumer demand.

Colouring foods of GNT1 are produced from edible and ripe fruits, vegetables or other plants. The resulting colouring foods are concentrates produced using physical procedures in which water is used as a processing aid, with evaporation as the final step.

* Dr. Andreas Reinhart and Dr. Markus Kraus are lawyers of the law firm meyer//meisterernst, Munich, Germany (info@meyer-meisterernst.de). Paul Collins is managing director of GNT International B.V. (pcollins@gnt-group.com).

1 The GNT Group – the world´s leading producer of colouring foods – have their own philosophy for processing.

2 European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs, OJ (EC) 1994 No. L 237/13.

3 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, OJ (EC) 2008 No. L 354/16.

4 Working Group of food chemistry experts of the federal states and the Federal Office for Consumer Protection and Food Safety.

5 Cf. Streinz, in Streinz (Ed.), EUV/EGV, 2003, Article 10 para. 23.

6 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 (EC) No. L 31/1.

7 A ban would only be permissible on grounds of public welfare in the sense of Article 36, TFEU, in which respect prior to issuing a ban, the country of destination has to complete a procedure under Regulation (EC) No. 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC; cf. Meyer, Regulation (EC) No. 764/2008 – The Principle of mutual Recognition with a new Label, EFFL 2009, p. 148–150.

Contrary to the situation with (additive) food colours, however, there is currently no specific legal framework that colouring foods should fall within.

The Community legislator using its legislative competence with regard to food colours, adopted some time ago the Directive 94/36/EC2 on colours for use in foodstuffs. This Directive established, with binding force, the catalogue of permitted (additive) colours and the associated terms governing their use. This Directive has recently been replaced by Regulation (EC) No. 1333/2008, which came into force on 20th January 2010.3 The material scope of application of the Regulation only covers (additive) food colours, and not colouring foods per se. In the absence of Community provisions, it is therefore the responsibility of Member States entrusted with the executory power of European food law, for fulfilling the remaining scope in the area of foods with colouring properties. Based on established administrative practice, the German monitoring authorities have called upon the definition criteria developed by the „Arbeitskreis lebensmittelchemischer Sachverständiger der Länder und des BVL“ (ALS).4 The bodies of the European Union are bound by the measures of the monitoring authorities in the country of origin on the basis of the principle of the administrative authority of the Member States set out in Article 4 para. 3 of the Treaty on the Functioning of the European Union (TFEU) (ex Article 10 TEC).5 The monitoring authorities of other Member States are bound by the principle of “mutual recognition” according to Article 34 TFEU (ex Article 28 TEC), provided that the colouring foods are consistent with the principles of food safety laid down in Regulation (EC) No. 178/2002.6/7 In order to establish a simple and practical differentiation test between (additive) food colours and colouring foods within the EU, the Working Group of Governmental Experts on Food Additives of the Standing Committee on the Food Chain and Animal Health (hereinafter: the Working Group), which supports the European Commission pursuant to

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Article 58 para. 1 of Regulation (EC) No. 178/2002, has embarked on the task of developing effective and practical differentiation criteria. Such criteria are to be set out in non-binding Guidance Notes and are to be consulted by the authorities in the Member States and by industry players in order to obtain assistance with differentiation issues. The Guidance Notes are therefore establishing an actual legal effect, since domestic courts and authorities will also orientate themselves to these in enforcing Community Law. In order to obtain reliable and consistent results, the content of the guidelines must therefore correspond to the legal specifications of the (additive) colour definition laid down within the Regulation; otherwise a decision based on the Guidance Notes will be illegal. The aim of this paper is to review and address the legal requirements applicable to colouring foods.

II. Legal Framework At the present time there are no specific provisions on colouring foods at a European level. In particular, there is no legal definition of such foods, although such a definition would have been helpful during the course of the recent revision of the law on additives. Colouring foods, in reference to Article 2 para. 1 of Regulation (EC) No. 178/2002, have to satisfy the horizontal provisions applicable to all foodstuffs as well as the vertical provisions for certain groups of products. In order to judge the product status and the labelling of colouring foods, the general provisions of Regulation (EC) No. 178/2002, Directive 2000/13/EC8 and in individual cases the specific provisions on novel foods have to be taken into account. Colouring foods are thus incorporated into a homogenous legal framework.

Finally, the definition of colours laid down in No. 2 of Annex I of Regulation (EC) No. 1333/20089 is of particular significance for the differentiation between (additive) food colours requiring authorisation and colouring foods which do not.

III. Differentiation criteria between colouring foods and colours A product that has colouring properties can be either a (colouring) food or an (additive) colour.

In this respect, a colouring food and an (additive)

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colour are mutually exclusive. The starting point for the classification of a product as a colouring food or (additive) colour is the colour definition contained in No. 2 of Annex I of Regulation (EC) No. 1333/ 2008 in addition to Article 3 para. 2 of Regulation (EC) No. 1333/2008. These regulations must be consulted for classification of a product in light of the historical development and the system of additive law under Community Law.10 In this test, the systematic starting point is initially the facts of exclusion of Article 3 para. 2 subsection a) ii) of Regulation (EC) No. 1333/2008. If the actual conditions of this exclusion within the Regulation are not met, the colour definition under No. 2 of Annex I of Regulation (EC) No. 1333/2008 that substantiates the additive term in the sense of Article 3 para. 2 subsection a) of Regulation (EC) No. 1333/2008 must be inspected. This follows on from the historical development of the law on additives. If the elements of the statutory definition laid down in the colour definition are met, it is an (additive) colour. Otherwise, the product to be classified must be qualified as a (colouring) food. In this case, the food must then meet the further, general requirements of Regulation (EC) No. 178/2002 (as well as the standards of food safety contained in Article 14, in particular).

1. Exceptional cases under Article 3 para. 2 lit. a) ii) of Regulation (EC) No. 1333/2008 The material scope of application of Regulation (EC) No. 1333/2008 extends to food additives in accor-

8 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, OJ (EC) 2000 No. L 109/29.

9 Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, OJ (EC) 2008 No. L 354/16.

10 Directive 2008/128/EC cannot be referred to for the differentiation between colouring foods and colours. It merely further specifies Directive 94/36/EC, according to its Recital No. 2. From the viewpoint of legal logic this means that Directive 2008/128/EC can only apply if the material scope of application of Directive 94/36/EC (or, rather, of Regulation (EC) No. 1333/2008 replacing that Directive) is given. In this respect, the substance already has to be classified as a colour in order to answer the question whether the substance satisfies the specific purity criteria in the sense of Directive 2008/128/EC. Hence this legal act is of no relevance to the issue of differentiation.

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dance with Article 1 para. 2 of Regulation (EC) No. 1333/2008. This field of application is restricted under the legal system through the exceptional case of Article 3 para. 2 subsection a) ii) of Regulation (EC) No. 1333/2008. Under this Regulation, 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 abstract way of looking at the issue removes the food there named (specifically flavours and/ or spices) from the additive term from the outset, and thus from the practical field of application of the Regulation. For this reason, this standard must be inspected as a first step in differentiating between (colouring) foods and (additive) colours.

2. Inspection of the colour definition, No. 2 of Annex I of Regulation (EC) No. 1333/2008 a. Systematic classification of the step If the requirements of exclusion under Article 3 para. 2 lit. a) ii) of Regulation (EC) No. 1333/2008 are not met, the differentiation (in the narrowest sense) between a (colouring) food and an (additive) colour must be made using the colour definition in No. 2 of Annex I of Regulation (EC) No. 1333/2008.

This colour definition substantiates the definition

11 Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption, OJ (EEC) 1989 No. L 40/27.

12 European Parliament and Council Directive 94/34/EC of 30 June 1994 amending Directive 89/107/EEC on the approximation of the laws of Member States concerning food additives authorized for use in foodstuffs intended for human consumption, OJ (EC) 1994 No. L 237/1.

13 European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs, OJ (EC) 1994, No. L 237/3.

14 European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs, OJ (EC) No. L 237/13.

15 European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners, OJ (EC) 1995 No. L 61/ 1.

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of food additives in the sense of Article 3 para. 2 sub-section a) of Regulation (EC) No. 1333/2008.

This follows from the historical development of the law on additives as well as the wording of the additive and colour terms, which continue to apply under the new legal regime of Regulation (EC) No. 1333/2008. b. Historical development and system of the law on additives Before the date of application of the Regulation (EC) No. 1333/2008, the general principles for the authorisation of additives that may be used in foods were laid down in the European Union in Directive 89/107/EEC11 (the so-called Framework Directive), amended by Directive 94/34/EC12. This framework directive was substantiated in 1994 through a total of three Directives. These were the Directive 94/35/EC13 on sweeteners for use in foodstuffs, Directive 94/36/EC14 on colours for use in foodstuffs and Directive 95/2/EC15 on food additives other than colours and sweeteners (the socalled Miscellaneous Additives Directive).

These three Directives have bindingly determined the list of permitted additives and the associated conditions for their use. This follows on from the system of the law on additives. Article 1 para. 2 of Directive 89/107/EEC has defined the term “food additive” as 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”.

The individual categories of materials into which the food additives so described are subdivided were listed in Annex I of Directive 89/107/EEC. The first category is that of colours.

Article 3 para. 1 of Directive 89/107/EEC further states that particular regulations for food additives of the categories in Annex I “shall be laid down in a comprehensive directive, including existing specific directives on particular categories of additives”.

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In accordance with Article 3 para. 2 of Directive 89/107/EEC, the individual directives must determine in particular and for each category the individual materials that may be used, as well as the conditions for such use. In addition to Directive 94/35/EC on sweeteners for use in foodstuffs and Directive 95/2/EC on food additives other than colours and sweeteners, Directive 94/36/EC on colours for use in foodstuff was one of the three specific directives that substantiate the Framework Directive 89/107/EEC. According to Article 1 para. 1 of Directive 94/36/EC, this directive was “a specific directive forming a part of the comprehensive directive within the meaning of Article 3 of Directive 89/107/EEC”.

In this respect, the colour directive has applied to a specific category of additives, namely that of (additive) colours. In this, colours were defined in Article 1 para. 2 of Directive 94/36/EEC as “[…] substances which add or restore colour in a food, and include natural constituents of foodstuffs and natural sources which are normally not consumed as foodstuffs as such and not normally used as characteristic ingredients of food. Preparations obtained from foodstuffs and other natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents are colours within the meaning of this Directive”.

There followed in Article 1 para. 3 of Directive 94/36/EC a restriction on the practical field of application of the directive, which – apart from some very minor editorial changes – is identical to the derogation rule of Article 3 para. 2 sub-section a) ii) of Regulation (EC) No. 1333/2008 presented above.

This arrangement that took place in the light of historical developments16 and the system of the law on additives clearly shows that the “colours” food additive category stated in Annex I of Directive 89/107/EEC was specified by Directive 94/36/EC and in this way substantiates the additive term.

A food concentrate with colouring properties that is added to a food product with the intention to impart its colouring effect and for no other technological reason and which does not meet the elements of the statutory definition of colours is therefore not a colour or additive.

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c. Historical wording of the colour and additive definition In the end, the substantiation of the additive term by using the term for colours also follows on from a comparison of the wording of the former colour definition in the sense of Article 1 para. 2 Clause 1 of Directive 94/36/EC with the wording of the term “food additive”.17 The definition of the colour term – like the definition of the additive term – was geared to constituents of foods or natural source materials which are not normally or generally consumed as foods nor used as a characteristic ingredient. On the other hand, the feature of technological reasons for use in the additive definition was substantiated in the colour definition by the element of the statutory definition “adds colour or restores colour to a food”.

The technological reasons for use, in the sense of Article 1 para. 2 of Directive 89/107/EEC, have come from the categories of food additives in accordance with Annex I of Directive 89/107/EEC and the further field of application of Directive 94/36/EC. The “for technological reasons” element of the statutory definition that needs to be satisfied in the additive definition was compared with the concrete element of the statutory definition “to add colour or restore colour to a food” of the colour definition.

Thus it follows from the wording that the colour directive simply has substantiated the additive directive. If a preparation with colouring properties is therefore added to a food, and when such preparation is itself eaten as a food and/or used as a characteristic food ingredient, then it is not a colour.

The additive definition cannot be called into play because the colour definition actually substantiates the additive definition. d. Continued applicability of the previous system of the law on additives The previous directives and decisions on additives were replaced by Regulation (EC) No. 1333/2008.

The definition of the colour term has been retained 16 Regarding the historical interpretation of Community law cf.

Schwarze, in: Schwarze (Ed.), EU-Kommentar, 2. ed. 2009, Article 220, para. 28.

17 Regarding the important of the literal interpretation cf. at last ECJ, Case C-366/08, – Zentrale zur Bekämpfung unlauteren Wettbewerbs e.V. / Adolf Darbo AG – , [official publication forthcoming], para. 55.

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largely unchanged by the European legislators in No. 2 of Annex I of Regulation (EC) No. 1333/2008.

Only the words “in view of” have been replaced in the German version by the words “compared with”.

In implementing Regulation (EC) No. 1333/2008 the Community legislators clearly did not intend a change to the colour definition or a change to the system of the law on additives.

The definition of additives in Article 3 para. 2 sub-section a) of Regulation (EC) No. 1333/2008 will therefore continue to be substantiated through the colour definition now contained in Annex I of Regulation (EC) No. 1333/2008. This follows on from the historical development, the wording and the system of the law on additives. If a food preparation with colouring properties is therefore not a colour, the product must be qualified as a food. Recourse to the additive definition is then legally not possible.

3. Actual conditions of the colour definition Under Community Law, the colour term is defined in No. 2 of Annex I of Regulation (EC) No. 1333/ 2008, which largely agrees with the colour definition of Directive 94/36/EC. According to Clause 1 of the colour definition, in each case the product is not a colour if it is used as a characteristic food ingredient or is eaten as a food.

This also corresponds to the basic premise according to the additives definition.18 In Clause 2 of the colour definition, the Community legislator selected an abstract way of looking at things when he determined that “preparations obtained from foodstuffs and other natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents are colours within the meaning of this Directive.” This legal fiction (“are colours”) represents a narrowly interpreted derogation rule that is not capable of analogy. In this respect, the wording of the rule forms the extreme limit of its interpretation. An interpretation and use of this regulation under Community Law that goes beyond the wording of the individual elements of the statutory definition is therefore illegal. In this respect, differenti-

18 See supra III.2.b.

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ation criteria deemed necessary to be laid down in Guidance Notes may not go beyond the wording of the colour definition. a. Object of the inspection The object of the inspection in the differentiation between (colouring) foods and (additive) colours are “preparations from foods and other edible natural source materials”.

Consequently, it is sufficient that the product being assessed is a “preparation from foods”. According to Article 2 para. 1 of Regulation (EC) No. 178/ 2002, foods are “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”.

As an alternative, according to the colour definition, one can also fall back on the source material used as a basis for the preparation if this is edible. b. Selective extraction One further actual condition of the colour definition is that the preparation is made from the food or the source material through a physical and/or chemical extraction, through which pigments are selectively extracted relative to their nutritive or aromatic constituents.

The wording of the colour definition may not be exceeded. Consequently, it depends on whether “pigments are selectively extracted relative to [...] nutritive or aromatic constituents”. Accordingly, it does not apply to the proportion of pigments before or after the processing of the products involved.

Rather, it depends more on the relation between pigment content on the one hand, and the nutritive or aromatic constituents on the other. Here it is sufficient if the proportion of the pigments compared to the nutritive constituents, or the proportion of pigments compared to the aromatic constituents is not significantly changed such that selective extraction has to be assumed. It is important to bear in mind that in practice any processing of a raw food material in a factory results in changes in the proportion of the pigments compared to the nutritive or aromatic constituents.

In assessing the relationships between pigments and the nutritive or aromatic constituents – once in reference to the starting food and once in reference

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to the concrete product – it must therefore be taken into account that not every change in proportions can justify the assumption of selective extraction.

Depending on the type of food and its cultivation and/or processing, as well as the fact that this is a natural product, many types of variation can additionally occur. This is quite normal, particularly with natural products, and therefore must be acceptable. Within each specific processing plant and through the associated procedures, additional changes are commonly made. For example, the pigment content of elderberry can differ greatly, dependent on the raw material – the colour value can range from below 70 units to 150 or even up to 250 units – so the proportion of pigments to the other constituents differs accordingly. The Guidance Notes19, however, indicate that the Commission and the Member States recognise that not every change in proportions can justify the assumption of selective extraction being effected, however the resultant selected wording “not significantly different” is not suitable to provide a practicable solution in line with the market. Rather, the question must be asked in this respect what is understood as ‘significantly different’ in individual cases. In this respect, an upper limit value (quantified in figures) that is in line with the market and other interests is required, which must be stipulated by the Regulatory legislator. In view of the administrative practice in a number of Member States and their executory powers with regard to European food law, a factor of 8-10 would seem both appropriate and practical.

In order to be able to gain a better impression of the actual conditions in the market with respect to foods with colouring properties, the working group of governmental experts on food additives have decided to carry out a so-called “road test”. The motivation for this was the knowledge that fundamental considerations still have to be made before the Guidance Notes can be seen as helpful for industry and the supervisory authorities. For this reason, the question needs to be addressed regarding which practical criteria – consistent with the legal position – can be used as a basis for the differentiation test in order to obtain results in line with market conditions. Discussions on this between, the Commission, the UKs’ Food Standards Agency (who are co-ordinating the “road-test” on behalf of the working group) and industry are currently ongoing.

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4. Summary regarding the differentiation criteria To classify a product as a (colouring) food or as an (additive) colour, the colour definition in No. 2 of Annex I of Regulation (EC) No. 1333/2008 and Article 3 para. 2 of Regulation (EC) No. 1333/2008 are to be exclusively used, pursuant to current legal provisions.

In the case of this qualification, the fact of exclusion of Article 3 para. 2 subsection a) ii) of Regulation (EC) No. 1333/2008 must initially be systematically inspected. In this respect, if the actual conditions of this regulation are not met, the product must be assessed using the colour definition – which substantiates the additive term – in accordance with No. 2 of Annex I of Regulation (EC) No. 1333/2008. If the elements laid down in this statutory definition are met, then it is an (additive) colour. Otherwise the product being assessed is a food (with its inherent colouring properties). In this case, the food (colouring food) must meet, in particular, the further general requirements of food safety contained in Regulation (EC) No. 178/2002. According to a declared opinion of the Community legislator, there are no risks to food safety or food controls.20 For the reasons presented, recourse to the additive definition is not applicable.

Additionally, Regulation (EC) No. 1333/2008 was published on 31st December 2008 in the Official Journal of the European Communities. In this respect, any Guidance Notes that substantiate the colour definition of Regulation (EC) No. 1333/2008 may therefore only be applied to products that are assessed after the Regulation came into force.

The sequences of tests resulting from this are as follows:

19 Cf. Criterion C 2 – WGA/05/08 Rev. 7.

20 This is overlooked by Gerstberger/Cremer, Colouring Foodstuffs: About the Peaks and Pitfalls of a Popular Alternative to Food Colours, EFFL 2010, p. 33 (35); idem, Farbe bekennen, Bio Recht 2010, p. 52. Cremer represents the CEFIC at the road test presently being conducted at FSA (London).

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Product with colouring properties

Yes

Was the product classified as a colouring food prior to 20.1.2010?

No

Yes

Is the product a food incorporated during the manufacturing of compound foods, because of its aromatic, sapid or nutritive properties together with a secondary colouring effect?

No No

Is the product neither consumed as a food nor used as a characteristic food ingredient?

Yes

No

Is the product a preparation obtained from foods and other edible natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents?

(Change in the proportion greater than factor 10)

Yes (Colouring) Food

Does the product meet the requirements of Regulation (EC) No. 178/2002 (particularly Article 14)?

(Additive) Colour

No

Yes Marketable (colouring) food

Non-marketable (colouring) food

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IV. Labelling Requirements 1. Declaration In principle, the labelling of foods is governed by the requirements of Directive 2000/13/EC. According to Article 3 para. 1 No. 1 of Directive 2000/13/ EC, pre-packaged foods may only be placed on the market commercially if their product name is indicated. According to Article 5 para. 1 of the Directive, the name under which a foodstuff is sold is the name determined in legal provisions or in the absence of such provisions the name customary amongst consumers and in the trade, or an adequate description of the foodstuff.

At the present time no legal provisions exist which explicitly regulate the labelling of colouring foods. Consequently, the customary name of the product (as recognised by consumers and in the trade in the sense of Article 5 para. 1 of Directive 2000/13/EC) has to be indicated. The opinion of consumers and in the trade has to be determined on the basis of the historically evolved view taken by circles participating in trade in foods, namely manufacturers, commercial traders and consumers.21 The relevant consumers and trade circles understand the term “colouring foods” to mean foods made from edible fruits, vegetables or plants which are obtained by means of mechanical-physical processes and are used in concentrated form in order to provide colour to foods. Examples of this are the use of elderberry and carrot concentrate in order to provide colour differentiation to ice cream. In this respect the mention of “concentrate (elderberry, carrot)” is required in principle, and should be sufficient. However, it is also possible to use more extensive, explanatory or descriptive references such as “concentrate (elderberry, carrot) for colouring”, so as to provide additional information to consumers. Until a specific provision on labelling at the European level is established, the bounds of what is permissible will be drawn solely by the ban on misleading labelling that is set out in Article 2 of Directive 2000/13/EC. The doubts expressed in certain parts of the literature22, namely that colouring foods could contain substances (especially additives) which do not have to be identified, are not reasonable. The relaxing of labelling requirements mentioned in Article 6 para.

4 lit. c) of Directive 2000/13/EC applies to all food-

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stuffs. Hence the matter is not a specific problem of colouring foods.

When labelling colouring foods, the general provisions on labelling also have to be observed. For example, the Community legislator adopted specific regulations on the labelling of allergenic ingredients (Directive 2003/89/EC23). According to the provisions, the allergenic foods mentioned in Directive 2003/89/EC (updated by Directive 2006/142/ EC24 and Directive 2007/68/EC25) have to be specified in the list of ingredients as soon as they are used as ingredients, even in very small quantities.

The labelling duties set out in these legal acts also have to be observed for colouring foods, so that consumers are comprehensively protected. Hence there is no risk potential affecting persons with allergies.

2. Labelling as “Natural” Colouring foods may be described as being “natural” since there are no specific labelling provisions regulating the use of the term “natural”. Until the adoption of corresponding provisions, the boundaries of what is permissible are drawn by the general prohibition on misleading labelling under Article 2 of Directive 2000/13/EC. According to the provision, the labelling of a foodstuff must not be capable of misleading the purchaser as to the nature, properties or method of manufacture. The criterion of misleading depends on the notions of a reasonable consumer on which the case law of the ECJ is based.26 Where a foodstuff is

21 Cf. Meyer/Streinz, BasisVO / LFGB, § 11 para. 19.

22 Cf. Gerstberger/Cremer, Colouring Foodstuffs: About the Peaks and Pitfalls of a Popular Alternative to Food Colours, EFFL 2010, p. 33 (36).

23 European Parliament and Council Directive 2003/89/EC of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients presents in foodstuffs, OJ (EC) 2003 No. L 308/15.

24 Commission Directive 2006/142/EC of 22 December 2006 amending Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuff, OJ (EC) 2006 No. L 368/110.

25 Commission Directive 2007/68/EC of 27 November 2007 amending Annex III a to Directive 2000/13/EC of the European Parliament and of the Council as regards certain food ingredients, OJ (EC) 2007 No. L 310/11.

26 Cf. ECJ, Case C-210/96, – Gut Springenheide – , Reports 1998, Page I-4657, para. 31.

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described as being “natural”, the knowledgeable consumer will expect a product obtained from natural raw materials. This is the case where colouring foods are used. These foodstuffs are made from edible and ripe fruits, vegetables or plants (and in this respect are precisely not artificial). Colouring foods can therefore be called “natural” as a matter of principle.

V. Relevance of the Novel Food Regulation The approval and use of novel foods and food ingredients is regulated in the European Union by Regulation (EC) No. 258/97 (the so-called Novel Food Regulation,27 hereinafter: NFR). The NFR subjects novel foods to an approval and notification procedure that is based on a safety assessment of the relevant foodstuff. According to the provisions, solely approved and/or notified novel foods and ingredients may be put on the market.28 According to Article 1 of the NFR, its material scope of application extends to the foods described in further detail in the four product categories, which were not used for human consumption to a significant degree within the Community prior to 15 May 1997. This means that the NFR does not apply to foods and food ingredients that were used for human consumption to a significant degree within the Community before 15 May 1997. In principle, this is a consideration applicable to colouring foods, which are traditional food ingredients. As a general rule, therefore, colouring foods will not fall within the scope of the NFR since the vast majority (at least) of the colouring foods on the Community market were already used for human consumption to a significant degree within the Community prior to 15 May 1997. The planned revision29 of the law

27 Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, OJ L 43, 14.2.1997, p. 1–6.

28 For a comparison of laws see Anker/Grossmann, Authorization of Genetically Modified Organisms: Precaution in US and EC Law, EFFL 2009, p. 3–22. Regarding the economic consequences of the approval procedure cf. Kraus, Risikominimierung neuartiger Lebensmittel durch Zulassungsrestrikitionen?, 2001.

29 Cf. Kraus/Meyer, Zu den Reformbestrebungen der Novel Food Verordnung – eine kritische Bestandsaufnahme, EWS 2009, p. 413–417.

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on novel foods30 will not change this fact, since the element of novelty is lacking. The scope of application of the NFR is therefore limited to cases where a food with colouring properties was used for human consumption to a significant degree within the Community after 15 May 1997. This primarily concerns “exotic raw products”, such as fruits with no prior evidence of significant consumption within the Community.

In addition, the manufacturing processes of colouring foods are not covered by the revision proposal of the NFR. It becomes clear from the 10th recital of the Common Position31 on revision of the NFR that solely the modification of a food ingredient, for example through selective extraction or the use of other parts of a plant that has not yet been used for human consumption within the Community, were intended to be covered by the scope of application of the (future) Novel Food Regulation.

However, this is precisely not the case with colouring foods obtained by means of mechanical-physical processes and used in concentrated form in order to impart colour to foods.32 Firstly, as regards such colouring foods, the threshold to selective extraction is not crossed,33 so that the requisite modification of the food ingredient in the sense of the draft Regulation is lacking. Secondly, only conventional methods of production are used. Thirdly, colouring foods were already consumed prior to the entry into force and hence prior to the scope of application in time of the Novel Food Regulation.

For these reasons no changes will arise for colouring foods from the future revision of the NFR. Solely selective extractions for the purpose of colouring will be governed in future by the law on additives (because they are (additive) colours) and by the law on novel foods. However, this does not give rise to problems because the approval procedure and safety tests are identical.

30 Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No. 258/97 COM (2007) 872 final.

31 Cf. Common Position of the Council of 7 September 2009 with a view to adopting a Regulation of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001, 11261/09.

32 Wrong in this respect Gerstberger/Cremer, Colouring Foodstuffs: About the Peaks and Pitfalls of a Popular Alternative to Food Colours, EFFL 2010, p. 33 (35 seq.).

33 See supra III.3.b.

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Colouring Foods: Product Status and Labelling Issues in the EU

VI. Conclusions The differentiation between (additive) colours and colouring foods has far-reaching consequences in practice. For example, foods are (in principle) governed by the principle of abuse, whereas (additive) colours have to undergo an approval procedure.

The practice of seeking a solution to such important legal problems on the basis of Guidance Notes gives rise to critical questions. Owing to their legal nature, the Guidance Notes are non-binding and, therefore, cannot be invoked in order to qualify a substance as a colouring food or as an (additive) colour. If one nevertheless relies on legally nonbinding Guidance Notes which are intended to be consulted by the authorities and courts within the context of the implementation of Community law

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in the Member States, as aids in order to differentiate between colouring foods and (additive) colours, the substance of the Guidance Notes has to comply with the legal requirements – taking into account the wording of legal provisions – in order to achieve appropriate results. Otherwise a decision taken on the basis of the Guidance Notes will be unlawful.

The determination of the requirements under which a substance will be qualified as an (additive) colour or as a colouring food is therefore so significant that it is to be reserved to the Community legislator. In this respect it is advisable for the Community legislator to resolve the differentiation issue between colouring foods and (additive) colours through a uniform definition that applies throughout the Community.

Dr. Andreas Reinhart Rechtsanwalt Dr. Andreas Reinhart, geb.

1971, hat Rechtswissenschaften an der Ludwig-Maximilians-Universität München studiert. Er promovierte an der Paris-Lodron-Universität Salzburg bei Prof. DDr. J. Michael Rainer. Seine Doktorarbeit befasste sich rechtsvergleichend mit dem anglo-amerikanischen Recht.

punktmäßig auf dem Gebiet des Lebensmittel- und Heilmittelwerberechts und dabei nicht nur forensisch, sondern auch beratend tätig. Er prüft geplante Werbebzw. Marketingmaßnahmen im Vorfeld auf ihre Zulässigkeit. Daneben berät und vertritt Herr Dr. Reinhart Apotheker in allen Fragen des Apothekenrechts.

Dr. Andreas Reinhart ist Partner der meyer.rechtsanwälte Partnerschaft.

Herr Dr. Reinhart ist durch eine Vielzahl wissenschaftlicher Publikationen als Kenner der von ihm bearbeiteten Rechtsgebiete ausgewiesen. So ist er etwa Herausgeber des Werkes „Praxishandbuch Kosmetische Mittel“ (Behr´s Verlag) und Autor des Buches „Kosmetikrecht“ (WVG Verlag). Herr Dr. Reinhart ist darüber hinaus Mitherausgeber des HWG-Kommentars Gröning (WVG Verlag). Ferner ist er Mitautor in dem Lebensmittelrecht-Kommentar von Meyer/Streinz (C.H. Beck Verlag), dem Wettbewerbsrecht-Kommentar (UWG) von Fezer (C.H. Beck Verlag) und in dem Handbuch des Fachanwalts Gewerblicher Rechtsschutz (Hrsg. Erdmann/Rojahn/Sosnitza; Luchterhand Verlag).

Seit 2005 ist er Lehrbeauftragter für Lebensmittelrecht an der TU München in Weihenstephan und seit 2010 auch als Lehrbeauftragter an der Paris-LondronUniversität Salzburg tätig.

Rechtsanwalt Dr. Reinhart betreut Mandate überwiegend aus der Lebensmittel-, Kosmetik- und Pharmaindustrie. Ergänzend kommen markenrechtliche Mandate hinzu, die sich von der Markeneintragung und -pflege, über die Pflege bis zur Abwehr von Ansprüchen Dritter erstrecken.

Ein Schwerpunkt seiner Tätigkeit liegt im Bereich der kosmetischen Mittel, von der Produktentwicklung, über Vertrieb und Vermarktung, bis hin zur Verteidigung des Kosmetikums gegenüber Behörden und vor Gerichten. Darüber hinaus ist Herr Dr. Reinhart schwer-

Neben seinen Lehraufträgen an der TU Weihenstephan und an der Universität Salzburg sowie seiner Dozententätigkeit bei der Deutschen Anwaltsakademie (DAA) ist Herr Dr. Reinhart als Referent auf verschiedenen Veranstaltungen tätig.

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Dr. Markus Kraus Maître en Droit (Bordeaux), Wirtschaftsjurist (Univ. Bayreuth) Dr. Markus Kraus, Jahrgang 1977, studierte von 1998 bis 2004 Rechtswissenschaft mit wirtschaftswissenschaftlicher Zusatzausbildung in Bayreuth (Wirtschaftsjurist Univ. Bayreuth), Bordeaux (Maîtrise en Droit) und Mainz (Erstes Staatsexamen).

In den Jahren 2000 und 2001 war er Mitarbeiter an der Forschungsstelle für Deutsches und Europäisches Lebensmittelrecht der Universität Bayreuth. Von 2004 bis 2006 war Herr Dr. Kraus Wissenschaftlicher Mitarbeiter am Institut für Europa- und Völkerrecht in Innsbruck.

Nach Abschluss seiner Promotion in Passau und des Referendariats war Dr. Kraus von 2009 bis 2011 als Rechtsanwalt in der Kanzlei meyer//meisterernst rechtsanwälte tätig, seit 2012 bei meyer. rechtsanwälte.

Während seines Studiums war Herr Dr. Kraus Stipendiat der Studienstiftung des deutschen Volkes sowie Stipendiat des Deutschen Akademischen Austausch­dienstes.

Der Schwerpunkt der Tätigkeit von Rechtsanwalt Dr. Kraus liegt im deutschen und europäischen Lebensmittelrecht sowie den daran angrenzenden

Rechtsgebieten. Er berät Mandanten in sämtlichen wettbewerbs- und ordnungsrechtlichen Fragestellungen.

Dies umfasst insbesondere die Einführung neuer Produkte, die Verkehrsfähigkeit von Lebensmitteln und deren Zutaten, sowie von Zusatzstoffen einschließlich deren Zulassung und Abgrenzungsfragen (Lebensmittel/Zusatzstoffe sowie Lebensmittel/Arzneimittel).

Herr Dr. Kraus ist Mitherausgeber der Textsammlung „Lebensmittelrecht“ (Verlag Österreich). Zudem ist seine Fachkenntnis durch zahlreiche einschlägige wissenschaftliche Publikationen im Bereich des deutschen, österreichischen und europäischen Lebensmittelrechts sowie des europäischen Wettbewerbsrechts ausgewiesen.

Herr Dr. Kraus berät in deutscher, englischer und französischer Sprache.

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