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

Herausgeber

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I. Introduction

Foods with their inherent colouring properties, usu-ally referred to as “colouring foods”, are a veryimportant alternative to the traditional (additive)food colours for the food industry. Their escalatingimportance to the food industry is driven by anincreasing understanding and awareness on behalfof the consumer with their resultant desire to havefood products coloured in the most natural, healthyand clean-label way possible. Colouring foods veryeffectively fulfil this growing consumer demand.Colouring foods of GNT1 are produced from edibleand ripe fruits, vegetables or other plants. Theresulting colouring foods are concentrates producedusing physical procedures in which water is used asa processing aid, with evaporation as the final step.

Contrary to the situation with (additive) foodcolours, however, there is currently no specific legalframework that colouring foods should fall within.

The Community legislator using its legislativecompetence with regard to food colours, adoptedsome time ago the Directive 94/36/EC2 on coloursfor use in foodstuffs. This Directive established,with binding force, the catalogue of permitted(additive) colours and the associated terms govern-ing their use. This Directive has recently beenreplaced by Regulation (EC) No. 1333/2008, whichcame into force on 20th January 2010.3 The materialscope of application of the Regulation only covers(additive) food colours, and not colouring foods perse. In the absence of Community provisions, it istherefore the responsibility of Member Statesentrusted with the executory power of Europeanfood law, for fulfilling the remaining scope in thearea of foods with colouring properties. Based onestablished administrative practice, the Germanmonitoring authorities have called upon the defini-tion criteria developed by the „Arbeitskreis lebens-mittelchemischer Sachverständiger der Länder unddes BVL“ (ALS).4 The bodies of the European Unionare bound by the measures of the monitoringauthorities in the country of origin on the basis ofthe principle of the administrative authority of theMember States set out in Article 4 para. 3 of theTreaty on the Functioning of the European Union(TFEU) (ex Article 10 TEC).5 The monitoringauthorities of other Member States are bound bythe principle of “mutual recognition” according toArticle 34 TFEU (ex Article 28 TEC), provided thatthe colouring foods are consistent with the princi-ples of food safety laid down in Regulation (EC)No. 178/2002.6/7

In order to establish a simple and practical differ-entiation test between (additive) food colours andcolouring foods within the EU, the Working Groupof Governmental Experts on Food Additives of theStanding Committee on the Food Chain and AnimalHealth (hereinafter: the Working Group), whichsupports the European Commission pursuant to

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* Dr. Andreas Reinhart and Dr. Markus Kraus are lawyers of the law firm meyer//meisterernst, Munich, Germany([email protected]). Paul Collins is managing directorof GNT International B.V. ([email protected]).

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 June1994 on colours for use in foodstuffs, OJ (EC) 1994 No. L 237/13.

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

4 Working Group of food chemistry experts of the federal states andthe 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 ofthe Council of 28 January 2002 laying down the general principlesand requirements of food law, establishing the European FoodSafety Authority and laying down procedures in matters of foodsafety, OJ (EC) No. L 31/1.

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


Andreas Reinhart, Markus Kraus and Paul Collins*

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Article 58 para. 1 of Regulation (EC) No. 178/2002,has embarked on the task of developing effectiveand practical differentiation criteria. Such criteriaare to be set out in non-binding Guidance Notes andare to be consulted by the authorities in the Mem-ber States and by industry players in order to obtainassistance with differentiation issues. The GuidanceNotes are therefore establishing an actual legaleffect, since domestic courts and authorities willalso orientate themselves to these in enforcingCommunity Law. In order to obtain reliable andconsistent results, the content of the guidelinesmust therefore correspond to the legal specifica-tions of the (additive) colour definition laid downwithin the Regulation; otherwise a decision basedon the Guidance Notes will be illegal. The aim ofthis paper is to review and address the legal require-ments applicable to colouring foods.

II. Legal Framework

At the present time there are no specific provisionson colouring foods at a European level. In particu-lar, there is no legal definition of such foods,although such a definition would have been helpfulduring the course of the recent revision of the lawon additives. Colouring foods, in reference to Article2 para. 1 of Regulation (EC) No. 178/2002, have tosatisfy the horizontal provisions applicable to allfoodstuffs as well as the vertical provisions for cer-tain groups of products. In order to judge the prod-uct status and the labelling of colouring foods, thegeneral provisions of Regulation (EC) No. 178/2002,Directive 2000/13/EC8 and in individual cases thespecific provisions on novel foods have to be takeninto account. Colouring foods are thus incorporatedinto a homogenous legal framework.

Finally, the definition of colours laid down inNo. 2 of Annex I of Regulation (EC) No. 1333/20089

is of particular significance for the differentiationbetween (additive) food colours requiring authorisa-tion and colouring foods which do not.

III. Differentiation criteria betweencolouring foods and colours

A product that has colouring properties can beeither a (colouring) food or an (additive) colour.In this respect, a colouring food and an (additive)

colour are mutually exclusive. The starting point forthe classification of a product as a colouring food or(additive) colour is the colour definition containedin 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 con-sulted for classification of a product in light of thehistorical development and the system of additivelaw under Community Law.10

In this test, the systematic starting point is ini-tially the facts of exclusion of Article 3 para. 2 sub-section a) ii) of Regulation (EC) No. 1333/2008. Ifthe actual conditions of this exclusion within theRegulation are not met, the colour definition underNo. 2 of Annex I of Regulation (EC) No. 1333/2008that substantiates the additive term in the sense ofArticle 3 para. 2 subsection a) of Regulation (EC)No. 1333/2008 must be inspected. This follows onfrom the historical development of the law on addi-tives. If the elements of the statutory definition laiddown in the colour definition are met, it is an (addi-tive) colour. Otherwise, the product to be classifiedmust be qualified as a (colouring) food. In this case,the food must then meet the further, generalrequirements of Regulation (EC) No. 178/2002 (aswell as the standards of food safety contained inArticle 14, in particular).

1. Exceptional cases under Article 3para. 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-

Colouring Foods: Product Status and Labelling Issues in the EU74 EFFL 2|2010

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

9 Regulation (EC) No. 1333/2008 of the European Parliament andof 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 differentiationbetween colouring foods and colours. It merely further specifiesDirective 94/36/EC, according to its Recital No. 2. From the view-point of legal logic this means that Directive 2008/128/EC canonly apply if the material scope of application of Directive94/36/EC (or, rather, of Regulation (EC) No. 1333/2008 replacingthat Directive) is given. In this respect, the substance alreadyhas to be classified as a colour in order to answer the questionwhether the substance satisfies the specific purity criteria in thesense of Directive 2008/128/EC. Hence this legal act is of norelevance 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 restrictedunder the legal system through the exceptional caseof Article 3 para. 2 subsection a) ii) of Regulation(EC) No. 1333/2008. Under this Regulation, foods,whether dried or in concentrated form, includingflavourings incorporated during the manufacturingof compound foods, because of their aromatic, sapidor nutritive properties together with a secondarycolouring effect, are not considered to be food addi-tives.

This abstract way of looking at the issue removesthe food there named (specifically flavours and/or spices) from the additive term from the outset,and thus from the practical field of applicationof the Regulation. For this reason, this standardmust be inspected as a first step in differen-tiating 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 3para. 2 lit. a) ii) of Regulation (EC) No. 1333/2008are not met, the differentiation (in the narrowestsense) between a (colouring) food and an (additive)colour must be made using the colour definition inNo. 2 of Annex I of Regulation (EC) No. 1333/2008.This colour definition substantiates the definition

of food additives in the sense of Article 3 para. 2sub-section a) of Regulation (EC) No. 1333/2008.This follows from the historical development of thelaw on additives as well as the wording of the addi-tive and colour terms, which continue to applyunder 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 theauthorisation of additives that may be used infoods were laid down in the European Union inDirective 89/107/EEC11 (the so-called FrameworkDirective), amended by Directive 94/34/EC12. Thisframework directive was substantiated in 1994through a total of three Directives. These were theDirective 94/35/EC13 on sweeteners for use in food-stuffs, Directive 94/36/EC14 on colours for use infoodstuffs and Directive 95/2/EC15 on food addi-tives other than colours and sweeteners (the so-called Miscellaneous Additives Directive).

These three Directives have bindingly deter-mined the list of permitted additives and the associ-ated conditions for their use. This follows on fromthe system of the law on additives. Article 1 para. 2of Directive 89/107/EEC has defined the term “foodadditive” as a

“substance not normally consumed as a food initself and not normally used as a characteristicingredient of food whether or not it has nutritivevalue, the intentional addition of which to food fora technological purpose in the manufacture, pro-cessing, preparation, treatment, packaging, trans-port or storage of such food results, or may be rea-sonably expected to result, in it or its by-productsbecoming directly or indirectly a component ofsuch foods”.

The individual categories of materials into whichthe food additives so described are subdivided werelisted in Annex I of Directive 89/107/EEC. The firstcategory is that of colours.

Article 3 para. 1 of Directive 89/107/EEC furtherstates that particular regulations for food additivesof the categories in Annex I

“shall be laid down in a comprehensive directive,including existing specific directives on particularcategories of additives”.

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

12 European Parliament and Council Directive 94/34/EC of 30 June1994 amending Directive 89/107/EEC on the approximation ofthe laws of Member States concerning food additives authorizedfor 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 June1994 on sweeteners for use in foodstuffs, OJ (EC) 1994, No.L 237/3.

14 European Parliament and Council Directive 94/36/EC of 30 June1994 on colours for use in foodstuffs, OJ (EC) No. L 237/13.

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

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In accordance with Article 3 para. 2 of Directive89/107/EEC, the individual directives must deter-mine in particular and for each category the indi-vidual materials that may be used, as well as theconditions for such use. In addition to Directive94/35/EC on sweeteners for use in foodstuffs andDirective 95/2/EC on food additives other thancolours and sweeteners, Directive 94/36/EC oncolours for use in foodstuff was one of the threespecific directives that substantiate the FrameworkDirective 89/107/EEC. According to Article 1 para. 1of Directive 94/36/EC, this directive was

“a specific directive forming a part of the compre-hensive directive within the meaning of Article 3of Directive 89/107/EEC”.

In this respect, the colour directive has applied toa specific category of additives, namely that of(additive) colours. In this, colours were defined inArticle 1 para. 2 of Directive 94/36/EEC as

“[…] substances which add or restore colour in afood, and include natural constituents of food-stuffs and natural sources which are normally notconsumed as foodstuffs as such and not normallyused as characteristic ingredients of food. Prepa-rations obtained from foodstuffs and other natu-ral source materials obtained by physical and/orchemical extraction resulting in a selective ex-traction of the pigments relative to the nutritiveor aromatic constituents are colours within themeaning of this Directive”.

There followed in Article 1 para. 3 of Directive94/36/EC a restriction on the practical field of ap-plication of the directive, which – apart from somevery minor editorial changes – is identical tothe derogation rule of Article 3 para. 2 sub-sectiona) ii) of Regulation (EC) No. 1333/2008 presentedabove.

This arrangement that took place in the light ofhistorical developments16 and the system of the lawon additives clearly shows that the “colours” foodadditive category stated in Annex I of Directive89/107/EEC was specified by Directive 94/36/ECand in this way substantiates the additive term.A food concentrate with colouring properties thatis added to a food product with the intention toimpart its colouring effect and for no other techno-logical reason and which does not meet the ele-ments of the statutory definition of colours is there-fore not a colour or additive.

c. Historical wording of the colour and additive definition

In the end, the substantiation of the additive termby using the term for colours also follows on from acomparison of the wording of the former colourdefinition in the sense of Article 1 para. 2 Clause 1of 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 – wasgeared to constituents of foods or natural sourcematerials which are not normally or generally con-sumed as foods nor used as a characteristic ingredi-ent. On the other hand, the feature of technologicalreasons for use in the additive definition was sub-stantiated in the colour definition by the element ofthe statutory definition “adds colour or restorescolour to a food”.

The technological reasons for use, in the sense ofArticle 1 para. 2 of Directive 89/107/EEC, have comefrom the categories of food additives in accordancewith Annex I of Directive 89/107/EEC and the fur-ther field of application of Directive 94/36/EC. The“for technological reasons” element of the statutorydefinition that needs to be satisfied in the additivedefinition was compared with the concrete elementof the statutory definition “to add colour or restorecolour to a food” of the colour definition.

Thus it follows from the wording that the colourdirective simply has substantiated the additivedirective. If a preparation with colouring propertiesis therefore added to a food, and when such pre-paration is itself eaten as a food and/or used as acharacteristic food ingredient, then it is not a colour.The additive definition cannot be called into playbecause the colour definition actually substantiatesthe additive definition.

d. Continued applicability of the previous systemof the law on additives

The previous directives and decisions on additiveswere 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 Wett-bewerbs e.V. / Adolf Darbo AG – , [official publication forthcom-ing], para. 55.

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largely unchanged by the European legislators inNo. 2 of Annex I of Regulation (EC) No. 1333/2008.Only the words “in view of” have been replaced inthe German version by the words “compared with”.In implementing Regulation (EC) No. 1333/2008the Community legislators clearly did not intend achange to the colour definition or a change to thesystem of the law on additives.

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

3. Actual conditionsof the colour definition

Under Community Law, the colour term is definedin No. 2 of Annex I of Regulation (EC) No. 1333/2008, which largely agrees with the colour defini-tion of Directive 94/36/EC.

According to Clause 1 of the colour definition, ineach case the product is not a colour if it is used as acharacteristic food ingredient or is eaten as a food.This also corresponds to the basic premise accord-ing to the additives definition.18

In Clause 2 of the colour definition, the Commu-nity legislator selected an abstract way of looking atthings when he determined that “preparationsobtained from foodstuffs and other natural sourcematerials obtained by physical and/or chemicalextraction resulting in a selective extraction of thepigments relative to the nutritive or aromatic con-stituents are colours within the meaning of thisDirective.” This legal fiction (“are colours”) repre-sents a narrowly interpreted derogation rule that isnot capable of analogy. In this respect, the wordingof the rule forms the extreme limit of its interpreta-tion. An interpretation and use of this regulationunder Community Law that goes beyond the word-ing of the individual elements of the statutory defi-nition is therefore illegal. In this respect, differenti-

ation criteria deemed necessary to be laid down inGuidance Notes may not go beyond the wording ofthe colour definition.

a. Object of the inspection

The object of the inspection in the differentiationbetween (colouring) foods and (additive) colours are“preparations from foods and other edible naturalsource materials”.

Consequently, it is sufficient that the product be-ing assessed is a “preparation from foods”. Accord-ing 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 asa basis for the preparation if this is edible.

b. Selective extraction

One further actual condition of the colour defini-tion is that the preparation is made from the food orthe source material through a physical and/or chem-ical extraction, through which pigments are selec-tively extracted relative to their nutritive or aro-matic constituents.

The wording of the colour definition may not beexceeded. Consequently, it depends on whether“pigments are selectively extracted relative to [...]nutritive or aromatic constituents”. Accordingly, itdoes not apply to the proportion of pigments beforeor after the processing of the products involved.Rather, it depends more on the relation betweenpigment content on the one hand, and the nutritiveor aromatic constituents on the other. Here it is suf-ficient if the proportion of the pigments comparedto the nutritive constituents, or the proportion ofpigments compared to the aromatic constituents isnot significantly changed such that selective extrac-tion has to be assumed. It is important to bear inmind that in practice any processing of a raw foodmaterial in a factory results in changes in the pro-portion of the pigments compared to the nutritiveor aromatic constituents.

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

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18 See supra III.2.b.

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to the concrete product – it must therefore be takeninto account that not every change in proportionscan justify the assumption of selective extraction.Depending on the type of food and its cultivationand/or processing, as well as the fact that this is anatural product, many types of variation can addi-tionally occur. This is quite normal, particularlywith natural products, and therefore must beacceptable. Within each specific processing plantand through the associated procedures, additionalchanges are commonly made. For example, the pig-ment content of elderberry can differ greatly,dependent on the raw material – the colour valuecan range from below 70 units to 150 or even up to250 units – so the proportion of pigments to theother constituents differs accordingly. The Guid-ance Notes19, however, indicate that the Commis-sion and the Member States recognise that notevery change in proportions can justify the assump-tion of selective extraction being effected, howeverthe resultant selected wording “not significantly dif-ferent” is not suitable to provide a practicable solu-tion in line with the market. Rather, the questionmust be asked in this respect what is understood as‘significantly different’ in individual cases. In thisrespect, an upper limit value (quantified in figures)that is in line with the market and other interests isrequired, which must be stipulated by the Regula-tory legislator. In view of the administrative prac-tice in a number of Member States and their execu-tory powers with regard to European food law, afactor of 8-10 would seem both appropriate andpractical.

In order to be able to gain a better impression ofthe actual conditions in the market with respect tofoods with colouring properties, the working groupof governmental experts on food additives havedecided to carry out a so-called “road test”. Themotivation for this was the knowledge that funda-mental considerations still have to be made beforethe Guidance Notes can be seen as helpful forindustry and the supervisory authorities. For thisreason, the question needs to be addressed regard-ing which practical criteria – consistent with thelegal position – can be used as a basis for the differ-entiation test in order to obtain results in line withmarket conditions. Discussions on this between, theCommission, the UKs’ Food Standards Agency(who are co-ordinating the “road-test” on behalf ofthe working group) and industry are currentlyongoing.

4. Summary regarding the differentiationcriteria

To classify a product as a (colouring) food or as an(additive) colour, the colour definition in No. 2 ofAnnex I of Regulation (EC) No. 1333/2008 and Arti-cle 3 para. 2 of Regulation (EC) No. 1333/2008 are tobe exclusively used, pursuant to current legal provi-sions.

In the case of this qualification, the fact of exclu-sion of Article 3 para. 2 subsection a) ii) of Regula-tion (EC) No. 1333/2008 must initially be systemati-cally inspected. In this respect, if the actual condi-tions of this regulation are not met, the productmust be assessed using the colour definition –which substantiates the additive term – in accor-dance with No. 2 of Annex I of Regulation (EC) No.1333/2008. If the elements laid down in this statu-tory definition are met, then it is an (additive)colour. Otherwise the product being assessed is afood (with its inherent colouring properties). In thiscase, the food (colouring food) must meet, in partic-ular, the further general requirements of food safetycontained in Regulation (EC) No. 178/2002. Accord-ing to a declared opinion of the Community legisla-tor, there are no risks to food safety or food con-trols.20 For the reasons presented, recourse to theadditive definition is not applicable.

Additionally, Regulation (EC) No. 1333/2008 waspublished on 31st December 2008 in the OfficialJournal of the European Communities. In thisrespect, any Guidance Notes that substantiate thecolour definition of Regulation (EC) No. 1333/2008may therefore only be applied to products that areassessed after the Regulation came into force.

The sequences of tests resulting from this are asfollows:


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 FoodColours, EFFL 2010, p. 33 (35); idem, Farbe bekennen, Bio Recht2010, p. 52. Cremer represents the CEFIC at the road testpresently being conducted at FSA (London).

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Colouring Foods: Product Status and Labelling Issues in the EUEFFL 2|2010 79

Product with colouring properties

Was the product classified as a colouring foodprior to 20.1.2010?

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

Is the product neither consumed as a food norused as a characteristic food ingredient?

No

(Colouring) Food

(Additive)Colour

Marketable (colouring) food

No

Yes

Yes

Does the product meet the requirements of Regulation

(EC) No. 178/2002 (particularlyArticle 14)?

Is the product a preparation obtained from foods andother edible natural source materials obtained byphysical and/or chemical extraction resulting in a

selective extraction of the pigments relative tothe nutritive or aromatic constituents?

(Change in the proportion greater than factor 10)

Yes

No

Yes

No

Non-marketable(colouring) food

Yes

No

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IV. Labelling Requirements

1. Declaration In principle, the labelling of foods is governed bythe requirements of Directive 2000/13/EC. Accord-ing to Article 3 para. 1 No. 1 of Directive 2000/13/EC, pre-packaged foods may only be placed on themarket commercially if their product name is indi-cated. According to Article 5 para. 1 of the Direc-tive, the name under which a foodstuff is sold is thename determined in legal provisions or in theabsence of such provisions the name customaryamongst consumers and in the trade, or an ade-quate description of the foodstuff.

At the present time no legal provisions existwhich explicitly regulate the labelling of colouringfoods. Consequently, the customary name ofthe product (as recognised by consumers and inthe trade in the sense of Article 5 para. 1 of Direc-tive 2000/13/EC) has to be indicated. The opinionof consumers and in the trade has to be deter-mined on the basis of the historically evolved viewtaken by circles participating in trade in foods,namely manufacturers, commercial traders andconsumers.21 The relevant consumers and tradecircles understand the term “colouring foods” tomean foods made from edible fruits, vegetablesor plants which are obtained by means of mechani-cal-physical processes and are used in concentratedform in order to provide colour to foods. Examplesof this are the use of elderberry and carrot con-centrate in order to provide colour differentiationto ice cream. In this respect the mention of“concentrate (elderberry, carrot)” is required inprinciple, and should be sufficient. However, it isalso possible to use more extensive, explanatoryor descriptive references such as “concentrate(elderberry, carrot) for colouring”, so as to provideadditional information to consumers. Until a spe-cific provision on labelling at the European levelis established, the bounds of what is permissiblewill be drawn solely by the ban on misleadinglabelling that is set out in Article 2 of Directive2000/13/EC.

The doubts expressed in certain parts of the liter-ature22, namely that colouring foods could containsubstances (especially additives) which do not haveto be identified, are not reasonable. The relaxing oflabelling requirements mentioned in Article 6 para.4 lit. c) of Directive 2000/13/EC applies to all food-

stuffs. Hence the matter is not a specific problem ofcolouring foods.

When labelling colouring foods, the general pro-visions on labelling also have to be observed. Forexample, the Community legislator adopted spe-cific regulations on the labelling of allergenic ingre-dients (Directive 2003/89/EC23). According to theprovisions, the allergenic foods mentioned in Direc-tive 2003/89/EC (updated by Directive 2006/142/EC24 and Directive 2007/68/EC25) have to be speci-fied in the list of ingredients as soon as they areused as ingredients, even in very small quantities.The labelling duties set out in these legal acts alsohave to be observed for colouring foods, so thatconsumers are comprehensively protected. Hencethere is no risk potential affecting persons withallergies.

2. Labelling as “Natural”

Colouring foods may be described as being “natu-ral” since there are no specific labelling provisionsregulating the use of the term “natural”. Until theadoption of corresponding provisions, the bound-aries of what is permissible are drawn by thegeneral prohibition on misleading labelling underArticle 2 of Directive 2000/13/EC. According to theprovision, the labelling of a foodstuff must notbe capable of misleading the purchaser as to thenature, properties or method of manufacture. Thecriterion of misleading depends on the notionsof a reasonable consumer on which the case lawof 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 Peaksand Pitfalls of a Popular Alternative to Food Colours, EFFL 2010,p. 33 (36).

23 European Parliament and Council Directive 2003/89/EC of10 November 2003 amending Directive 2000/13/EC as regardsindication of the ingredients presents in foodstuffs, OJ (EC) 2003No. L 308/15.

24 Commission Directive 2006/142/EC of 22 December 2006amending Annex IIIa of Directive 2000/13/EC of the EuropeanParliament and of the Council listing the ingredients which mustunder 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 amend-ing Annex III a to Directive 2000/13/EC of the European Parlia-ment 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 knowledgeableconsumer will expect a product obtained from natu-ral raw materials. This is the case where colouringfoods are used. These foodstuffs are made from edi-ble and ripe fruits, vegetables or plants (and in thisrespect are precisely not artificial). Colouring foodscan therefore be called “natural” as a matter of prin-ciple.

V. Relevance of the Novel FoodRegulation

The approval and use of novel foods and food ingre-dients is regulated in the European Union by Regu-lation (EC) No. 258/97 (the so-called Novel FoodRegulation,27 hereinafter: NFR). The NFR subjectsnovel foods to an approval and notification proce-dure that is based on a safety assessment of the rel-evant foodstuff. According to the provisions, solelyapproved and/or notified novel foods and ingredi-ents may be put on the market.28

According to Article 1 of the NFR, its materialscope of application extends to the foods describedin further detail in the four product categories,which were not used for human consumption to asignificant degree within the Community prior to15 May 1997. This means that the NFR does notapply to foods and food ingredients that were usedfor human consumption to a significant degreewithin the Community before 15 May 1997. In prin-ciple, this is a consideration applicable to colouringfoods, which are traditional food ingredients. As ageneral rule, therefore, colouring foods will not fallwithin the scope of the NFR since the vast majority(at least) of the colouring foods on the Communitymarket were already used for human consumptionto a significant degree within the Community priorto 15 May 1997. The planned revision29 of the law

on novel foods30 will not change this fact, since theelement of novelty is lacking. The scope of applica-tion of the NFR is therefore limited to cases where afood with colouring properties was used for humanconsumption to a significant degree within theCommunity after 15 May 1997. This primarily con-cerns “exotic raw products”, such as fruits with noprior evidence of significant consumption withinthe Community.

In addition, the manufacturing processes ofcolouring foods are not covered by the revision pro-posal of the NFR. It becomes clear from the 10th

recital of the Common Position31 on revision of theNFR that solely the modification of a food ingredi-ent, for example through selective extraction or theuse of other parts of a plant that has not yet beenused for human consumption within the Commu-nity, were intended to be covered by the scope ofapplication of the (future) Novel Food Regulation.However, this is precisely not the case with colour-ing foods obtained by means of mechanical-physi-cal processes and used in concentrated form inorder to impart colour to foods.32 Firstly, as regardssuch colouring foods, the threshold to selectiveextraction is not crossed,33 so that the requisitemodification of the food ingredient in the sense ofthe draft Regulation is lacking. Secondly, only con-ventional methods of production are used. Thirdly,colouring foods were already consumed prior to theentry into force and hence prior to the scope ofapplication in time of the Novel Food Regulation.For these reasons no changes will arise for colour-ing foods from the future revision of the NFR.Solely selective extractions for the purpose ofcolouring will be governed in future by the law onadditives (because they are (additive) colours) andby the law on novel foods. However, this does notgive rise to problems because the approval proce-dure and safety tests are identical.

EFFL 2|2010 81

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 conse-quences of the approval procedure cf. Kraus, Risikominimierungneuartiger Lebensmittel durch Zulassungsrestrikitionen?, 2001.

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

30 Proposal for a Regulation of the European Parliament and ofthe 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 andof the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 andCommission 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 FoodColours, EFFL 2010, p. 33 (35 seq.).

33 See supra III.3.b.

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VI. Conclusions

The differentiation between (additive) colours andcolouring foods has far-reaching consequences inpractice. For example, foods are (in principle) gov-erned by the principle of abuse, whereas (additive)colours have to undergo an approval procedure.The practice of seeking a solution to such impor-tant legal problems on the basis of Guidance Notesgives rise to critical questions. Owing to their legalnature, the Guidance Notes are non-binding and,therefore, cannot be invoked in order to qualify asubstance as a colouring food or as an (additive)colour. If one nevertheless relies on legally non-binding Guidance Notes which are intended to beconsulted by the authorities and courts within thecontext of the implementation of Community law

in the Member States, as aids in order to diffe-rentiate between colouring foods and (additive)colours, the substance of the Guidance Notes has tocomply with the legal requirements – taking intoaccount the wording of legal provisions – in orderto achieve appropriate results. Otherwise a decisiontaken on the basis of the Guidance Notes will beunlawful.

The determination of the requirements underwhich a substance will be qualified as an (additive)colour or as a colouring food is therefore so signifi-cant that it is to be reserved to the Community leg-islator. In this respect it is advisable for the Com-munity legislator to resolve the differentiation issuebetween colouring foods and (additive) coloursthrough a uniform definition that applies through-out the Community.


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

Herr Dr. Reinhart ist durch eine Vielzahl wissenschaftlicher Publikationen als Ken-ner der von ihm bearbeiteten Rechtsge-biete ausgewiesen. So ist er etwa Heraus-geber des Werkes „Praxishandbuch Kos-metische Mittel“ (Behr´s Verlag) und Autor des Buches „Kosmetikrecht“ (WVG Verlag). Herr Dr. Reinhart ist darüber hin-aus Mitherausgeber des HWG-Kommen-tars Gröning (WVG Verlag). Ferner ist er Mitautor in dem Lebensmittelrecht-Kom-mentar von Meyer/Streinz (C.H. Beck Ver-lag), dem Wettbewerbsrecht-Kommentar (UWG) von Fezer (C.H. Beck Verlag) und in dem Handbuch des Fachanwalts Gewerblicher Rechtsschutz (Hrsg. Erd-mann/Rojahn/Sosnitza; Luchterhand Verlag).

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.

Rechtsanwalt Dr. Andreas Reinhart, geb. 1971, hat Rechtswissenschaften an der Ludwig-Maximilians-Universität Mün-chen studiert. Er promovierte an der Paris-Lodron-Universität Salzburg bei Prof. DDr. J. Michael Rainer. Seine Doktor-arbeit befasste sich rechtsvergleichend mit dem anglo-amerikanischen Recht.

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

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

Rechtsanwalt Dr. Reinhart betreut Man-date überwiegend aus der Lebensmittel-, Kosmetik- und Pharmaindustrie. Ergän-zend kommen markenrechtliche Manda-te hinzu, die sich von der Markeneintra-gung 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 gegen-über Behörden und vor Gerichten. Darü-ber hinaus ist Herr Dr. Reinhart schwer-

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Rechtsgebieten. Er berät Mandanten in sämtlichen wettbewerbs- und ordnungs-rechtlichen Fragestellungen. Dies umfasst insbesondere die Einführung neuer Produkte, die Verkehrsfähigkeit von Lebensmitteln und deren Zutaten, sowie von Zusatzstoffen einschließlich deren Zulassung und Abgrenzungsfra-gen (Lebensmittel/Zusatzstoffe sowie Lebensmittel/Arzneimittel).

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Herr Dr. Kraus berät in deutscher, engli-scher und französischer Sprache.

Dr. Markus Kraus, Jahrgang 1977, studier-te von 1998 bis 2004 Rechtswissenschaft mit wirtschaftswissenschaftlicher Zusatz-ausbildung in Bayreuth (Wirtschaftsjurist Univ. Bayreuth), Bordeaux (Maîtrise en Droit) und Mainz (Erstes Staatsexamen). In den Jahren 2000 und 2001 war er Mit-arbeiter an der Forschungsstelle für Deutsches und Europäisches Lebensmit-telrecht der Universität Bayreuth. Von 2004 bis 2006 war Herr Dr. Kraus Wissen-schaftlicher Mitarbeiter am Institut für Europa- und Völkerrecht in Innsbruck. Nach Abschluss seiner Promotion in Pas-sau und des Referendariats war Dr. Kraus von 2009 bis 2011 als Rechtsanwalt in der Kanzlei meyer//meisterernst rechtsan-wälte tätig, seit 2012 bei meyer.rechtsanwälte.

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

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

Maître en Droit (Bordeaux), Wirtschaftsjurist (Univ. Bayreuth)

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Documents

Colouring Foods: Product Status and Labelling Issues in the EU