BASIC ASPECTS AND PRINCIPLES

V. BASIC ASPECTS AND PRINCIPLES

The additives legislation described in this paper pertains to all food additives put on the market in the EU, either additives preparations as such, or additives incorporated in food- stuffs, or also intermediates for the manufacture of foods for direct consumption. In princi- ple, it also applies to all imports. However, for certain imported products, specific addi- tional authorizations were agreed by special agreements. An example is the authorization to import wine containing erythorbate from Australia (29).

In the harmonization process undertaken in the Union, one should distinguish be- tween the principles: the legal part of the Directives and the systematic part (the Directive Annexes with tables). The lists with additives and conditions of use—the systematic part—have been split into three separate Directives: on sweeteners (27), on colors (28), and on all the other additives, or ‘‘miscellaneous’’ additives (10). Each of these three Directives also carries a legal part, with principles, which may be different in some respects for sweeteners, colors, and miscellaneous additives.

A. Framework Directive (89/107/EEC)

The main principles on additives legislation are laid down essentially in the framework Directive on additives (4). This framework Directive on additives establishes that additives shall be ruled by positive list, which also lays down the conditions of use, that is, only additives which are listed may be used, to the exclusion of all others.

Furthermore, a Community procedure is foreseen for trial introduction of new addi- tives, starting in one member state, but then either to be extended to the whole Community or revoked (Art. 5).* It should be stressed that this trial procedure is not meant for broaden- ing of authorizations of additives which are already approved in the EU. Although support from member state administrations is most helpful, any broadening of existing authoriza- tions (use level or extension to new food categories) is best requested through the Commis- sion.

Directive 89/107/EEC sets criteria for an additive to be approved (Annex II). These criteria are presented in Section V.C. It also establishes 24 functions of food additives (called ‘‘categories of additives,’’ Annex I of the Directive) (see Table 3 ). The precise functions of additives, which are open to endless debate, do not have an important role in the Directives. They are merely used in the titles of the Directives and in their Annex

* It should be noted that a somewhat similar but still different authorization for a trial introduction of an additive existed earlier, e.g., in German law. This is the so-called Ausnahmegenehmigung nach § 37 LMBG. This earlier German trial authorization procedure is not the transcription of the European Article 5 of 89/107/ EEC. The German text differs in that it limits the authorization to one foodstuff, to a limited tonnage of that foodstuff, and to one company. Further requirements are set in that German leglation. The German text, but not the European Directive, furthermore allows a possible extension of the trial period. The trial authorization, according to Directive 89/107/EEC, as well as according to German law, is temporarily bypassing democratic control by Parliament. The idea is to escape from sluggish administrative procedures stifling innovation. How- ever, the limitation to two years for the whole process, including the final parliamentary confirmation of the * It should be noted that a somewhat similar but still different authorization for a trial introduction of an additive existed earlier, e.g., in German law. This is the so-called Ausnahmegenehmigung nach § 37 LMBG. This earlier German trial authorization procedure is not the transcription of the European Article 5 of 89/107/ EEC. The German text differs in that it limits the authorization to one foodstuff, to a limited tonnage of that foodstuff, and to one company. Further requirements are set in that German leglation. The German text, but not the European Directive, furthermore allows a possible extension of the trial period. The trial authorization, according to Directive 89/107/EEC, as well as according to German law, is temporarily bypassing democratic control by Parliament. The idea is to escape from sluggish administrative procedures stifling innovation. How- ever, the limitation to two years for the whole process, including the final parliamentary confirmation of the

The framework Directive sets furthermore the conditions for selling additives prepa- rations as such (Arts. 7 through 10): (1) additives not for sale to the ultimate consumer (e.g., to food manufacturers or to dealers) and (2) additives for sale to the ultimate con- sumer (such as, e.g., intense sweeteners for tabletop use, or baking powder for the kitchen. The core of these conditions—for both (1) and (2)—are the precise labeling requirements for such preparations.

B. Additive Function Definitions

These definitions may be helpful in deciding whether a substance should be classified as an additive. The reverse question remains unanswered, whether a substance with a clearly technological function, a function which does not occur in Annex I of the framework Directive ( Table 3 ), can therefore be certified not to be an additive. A typical example of such a case could be an enzyme inhibitor.

It should be pointed out that, remarkably enough, the categories listed in the Annex to this Directive are not completely identical with the ones already adopted earlier for labeling purposes (see Table 2 )* (18). The definition for sweeteners is presented below in Section VII.A.1 and for colors in Section VII.B.2.

C. Criteria for Additive Authorization

The essential criteria for approval are (1) safety, (2) not misleading the consumer, and also (3) the presence of a need, a technological and/or economic justification. Normally

a case of need is established by demonstration of a technological problem to which the additive brings an economic solution. Such a dossier is best underscored by letters of support from interested user industries. Merely economic justifications (price) are more difficult to defend, but it would be hypocritical to maintain that they cannot in themselves sufficiently justify the use of certain safe additives. It should be obvious that advantages to both the consumer and the manufacturer are the driving forces behind all efforts to manufacture foods economically.

The exact formulation of each of the criteria can be criticized. The philosophi- cal question can be asked, for example, whether added colors do not always—in one way or another—mislead the consumer. But the consumer may in fact like to believe that things have more color than they do in reality, or even insist on certain colors for specific foods which are naturally colorless or weak in color (e.g., green mint). Unmitigated ab- sence of risk to health is not warranted either. It is sometimes a tradeoff. Few cases are clearer than the nitrites, which have a recognized toxicity. Still they are properly recom- mended as the preservatives of choice to counter the far greater risk of botulism in meat products.

* Table 1 [Annex I of the additives framework Directive 89/107/EEC (4)] lists ‘‘sequestrant’’ and ‘‘en- zyme ,’’ as well as ‘‘propellant and packaging gas.’’ These do not occur in Table 2 [Annex II of amendment 93/102/EC to the Labeling Directive (18)]. Instead of ‘‘propellant and packaging gas,’’ Table 2 mentions only

Table 2 The Function Categories of Additives Established for Labeling Purposes

Categories of ingredients which must be designated by the name of their category followed by their specific name or EC number

Color Preservative Antioxidant Emulsifier Thickener Gelling agent Stabilizer Flavor enhancer Acid Acidity regulator Anticaking agent Modified starch Sweetener Raising agent Antifoaming agent Glazing agent Emulsifying salts Flour treatment agent Firming agent Humectant Bulking agent Propellant gas

Source : Ref. 18.

But the same is true even for many regular foods. Eggs contain cholesterol; frequent sugar consumption constitutes a risk of caries, etc. That is no reason to ban their reasonable use as nutritious and tasty foodstuffs.

The requirement for a case of need is a typical European matter, originating in the legislation of several member states. It does not exist in the same way, for example, in the United States. The reason for using this approach is to avoid overly long lists of authorizations which are not really being used. Yet it is certainly stifling innovation. Al- though it does not entail an obligation to start real use afterwards, manufacturers are sometimes reluctant to lend their support to a request for authorization. Indeed, trials with a substance which may in the end not get an authorization may still consume scarce development money, spent before they are willing to endorse a request for authorization.

That the case-of-need approach is stifling innovation is substantiated furthermore by the fact that several additives have turned out to be very useful for applications quite different from the one(s) for which they were conceived in the first place. For example, polyols designed to act as sweeteners are now also finding widespread application as humectants. Carboxymethyl cellulose, a thickener, can be used as a barrier substance on

Furthermore, the very fact that the lengthy and expensive process of authorization ends with a political decision, is economic nonsense. Industry needs certainty to operate. If all the criteria for the authorization of an ingredient are fulfilled, and its safety is proved, it is unacceptable that an arbitrary political decision at the end could waste the enormous effort spent.

D. Additive Safety and the Scientific Committee for Food

As to safety, the Commission’s Scientific Committee for Food (SCF) plays a cardinal role. It sets acceptable daily intakes (ADIs) which ought to guide the administrators in establishing safe conditions of use. (The SCF does not have a mandate to grant an authori- zation for use; that is a political decision, taken, as a rule, in line with opinions delivered in the SCF; see Section X.B). However, the vastness of the European area, with its ex- tremely varied food consumption patterns, complicates this establishing of acceptable con- ditions of use for the whole Community. Although an official effort for surveying is under- way, the problem of unavailability of reliable data for the whole EU on the intake of specific foodstuffs, and hence of additives, remains to be solved.

Although the primary aim of the undertaking was merely to open the market by harmonizing existing legislation, the proceedings have allowed two important new de- velopments. First, some new additives were taken up directly into the Community leg- islation, without prior authorization in any individual member state (e.g., the case of neohesperidine dihydrochalcone, or NHDC). Second, in order to underscore the safety basis of the new rules, the SCF has now set ADIs for additives which had been in use for a long time without earlier adequate safety evaluations (such as for the glycerol esters of wood rosin).

Guidance on how to submit a new additive to the SCF is given in a brochure pub- lished by the European Commission (30). No rigid program of studies has been estab- lished. In general the following are required for the dossier: the results of acute toxicity, genotoxicity studies, metabolic and pharmacokinetics studies, subchronic toxicity studies, reproduction and teratogenicity studies, and chronic toxicity and carcinogenicity studies. Omission of certain investigations, or inclusion of additional ones, should be justified and explained. The studies carried out should be reported on in their entirety, with evaluation of the results and conclusions.

In general, the SCF establishes a no Effect level or no Adverse effect level (NOEL; NOAEL) and derives an ADI from this. This ADI is the guide figure for assigning maxi- mum use levels. A list of the ADIs of the EU authorized additives can be found in Tables

1 and 2 . Note, however, that ADI values are subject to change. The tables reflect the status on April 17, 1999. The ADIs set by the SCF sometimes differ from the ADIs set by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

As a standard, the ADI is expressed numerically, in milligrams per kilogram body weight. For very high ADIs the indication can be given in grams. For unproblematic additives, A (acceptable) or NS (not specified) can be indicated as non-numerical indica- tions. An ADI on its own, does not mean very much. For risk assessment, the ADI of an additive must be seen together with the dose required to achieve its technological effect. Recently fears have been voiced that an ADI per se is not a good enough tool to assess the risks of an additive. It should be stressed that, as a rule, the ADI is established for a

E. Food Additives as Agents Causing Other Adverse Reactions and as Allergens

Contrary to widespread and persistent belief, approved food additives do not frequently cause real allergic reactions. For example, regular food ingredients (fish, egg, etc.) are by far the most frequently proven food allergens. Allergy refers to a specific type of immune reaction. The real mechanism of a reaction being many times unclear, intolerance, as a more general term, is to be preferred in many discussions. It should be stressed that intoler- ance reactions are individual, and are not part of a general toxicity syndrome. A food component causing very serious problems to one individual may be completely innocuous to the majority of the population at large.

Indeed, people suffering from a specific food intolerance are often relative minorities of the population. Elimination of each of these problems by prohibition of all such specific causative agents in foodstuffs would be absolutely impossible and largely disruptive for major segments of the food chain. Hence the proper legislative approach to this issue is to impose correct indication of intolerance agents on the food so that sufferers can avoid foods they do not tolerate well. As most real intolerance accidents are not due to prepack- aged foods but to foods in restaurants, private occasions, and catering, additional measures should be considered for these. The responsibility for information on nonprepackaged foods remains primarily the responsibility of the individual member states. Hence the rules, if any are in existence, can be different from one member state to another.

A legislative measure of the EU is in preparation to impose warning labeling of prepackaged foods for agents of severe intolerance. Most important in this respect is the list of specific agents, the indication of which will be rendered mandatory. The development of that list is paralleled by the Codex Alimentarius standard on labeling.

In the latest EU Commission proposal on warning labeling for intolerance-causing agents—based on SCF advice (31)—only one set of additives was listed for warnings on the label: the sulfites, at concentrations of at least 10 mg/kg (32). The fact that the sulfites are as yet the only additives in the list proposed (along with nine natural foods) underscores quite strikingly the statements in this section. As far as additives are concerned, the Codex Alimentarius list is also limited to sulfites (ⱖ10 mg/kg) (33). (See also Sections V.J and V.N.).

F. Combination of Additive Usage

An important principle in the EU additives Directives, though not explicitly stated in the legal part of the texts, is the option to combine in a single foodstuff the use of all additives corresponding to all authorizations applicable to that foodstuff. Of course, only very sel- dom will it be necessary to use all authorized additives together and or use them up to their maximum use level.

One of the important consequences of this principle in the context of the sweeteners Directives (27) is that all sweeteners authorized for a foodstuff can be combined, each one up to its maximum use level, intense sweeteners and polyols, independently or mixed. In several places in the annexes of the miscellaneous additives Directive (10), specific limitations to that principle are given. See, for example, the benzoates (p. 17) and the synthetic antioxidants (p. 25) (or for colors, for an exception, see Section VII.B.1.b). These cases normally pertain to additives to which a ‘‘group ADI’’ was assigned. A group ADI sets the maximum intake only for the sum of the interchangeable additives of that group, One of the important consequences of this principle in the context of the sweeteners Directives (27) is that all sweeteners authorized for a foodstuff can be combined, each one up to its maximum use level, intense sweeteners and polyols, independently or mixed. In several places in the annexes of the miscellaneous additives Directive (10), specific limitations to that principle are given. See, for example, the benzoates (p. 17) and the synthetic antioxidants (p. 25) (or for colors, for an exception, see Section VII.B.1.b). These cases normally pertain to additives to which a ‘‘group ADI’’ was assigned. A group ADI sets the maximum intake only for the sum of the interchangeable additives of that group,

G. Unprocessed Foodstuffs and Foodstuffs Without Additives

A definition of ‘‘unprocessed’’ foodstuffs cannot be found in the framework Directive but is given in the miscellaneous additives Directive (10), as well as in the colors Direc- tive* (28). As a rule, additives are prohibited in all unprocessed foodstuffs. The definition of unprocessed foodstuffs in the context of the EU additives Directives differs slightly from the one of Codex Alimentarius in that deep-freezing is not considered as processing in the EU. Consequently, deep-frozen foods should be devoid of additives.

Furthermore, the application of colors is prohibited in the foods listed in Art. 2 § 3a) of the colors Directive (28) whilst a list of prohibitions against ‘‘miscellaneous’’ addi- tives can be found in Art. 2 of the corresponding Directive (10).

The sweeteners Directives have been written with nearly identical descriptors of food categories repeated for each sweetener and with a limited number of authorizations. This alleviates the need for a clause on unprocessed foodstuffs or for a table with sweet- ener-free foodstuffs.

H. Organic Produce

Certain additives are authorized for use in foodstuffs from organic production. None of the sweeteners are authorized. Colors are neither authorized, provided that the calcium carbonates are considered noncolors [i.e., as miscellaneous additives (10)]. With the excep- tion of karaya gum, all the authorized additives also occur in Annex I of the miscellaneous additives Directive (10). This means that they are all carrying a non-numerical ADI, and can be used ‘‘quantum satis’’ (QS; see Section V.K). The only additive which carries a numerical ADI in the list of additives authorized for organic produce are the tartrates. The complete list of these additives is given in Table 3 in this chapter.

I. Traditional Foods

The most striking example of political compromise in the elaboration of the European additives legislation is without doubt the amendment to the additives framework Directive. This amendment authorizes ‘‘. . . the Member States to maintain the prohibition of certain additives in the production of certain foodstuffs considered traditional . . .’’ (34). This exception—a fundamental regression to national protectionism, away from the ideal of full European harmonization—was originally requested by Germany as an amendment to the sweeteners Directive (27). The intention was to prevent the use of intense sweeteners in beers brewed according to the Reinheitsgebot (German law on ‘‘purity’’ of beer).

* Art. 2 § 11 of the colors Directive (27) and Art. 2 § 3a of the miscellaneous Directive hold a definition of unprocessed foods, as well as a nonlimiting list of treatments which do not make a food into a processed one: ‘‘‘unprocessed’ means not having undergone any treatment resulting in a substantial change in the original state of the foodstuffs; however, the foodstuffs may have been, for example, divided, parted, severed, boned, minced, skinned, pared, peeled, ground, cut, cleaned, trimmed, deep-frozen or frozen, chilled, milled or husked,

Table 3 Ingredients of Nonagricultural Origin: Food Additives, Including Carriers

Specific

E number

Name

conditions

E170 Calcium carbonates

E270 Lactic acid

E290 Carbon dioxide

E296 Malic acid

E300 Ascorbic acid

E322 Lecithins

E330 Citric acid

E334 Tartaric acid (L(⫹)—)

E335 Sodium tartrate

E336 Potassium tartrate

E400 Alginic acid

E401 Sodium alginate

E402 Potassium alginate

E406 Agar

E410 Locust beam gum

E412 Guar gum

E413 Tragacanth gum

E414 Arabic gum

E415 Xanthan gum

E416 Karaya gum

E440 Pectin

E500 Sodium carbonates

E501 Potassium carbonates

E503 Ammonium carbonates

E504 Magnesium carbonates

E516 Calcium sulphate

CR

E938 Argon

E941 Nitrogen

E948 Oxygen

Source : Ref. 54. CR ⫽ carrier.

This damaging change was vigorously opposed by industry and by the EP as well. After months of stalemate in the proceedings on the sweeteners Directive (27), a compro- mise was reached. Instead of limiting the exception merely to Germany’s beers, it was decided then that all member states would equally be authorized to make certain exemp- tions for ‘‘traditional’’ foodstuffs from the horizontal legislation on additives in general, not just on sweeteners. This agreement has now been laid down in a Directive amending the framework Directive on additives (26).

This additional and complicated rule prevents the use of the newly authorized addi- tives in the manufacture of its declared traditional products, sold as such, in the territory of the requesting member state. This amendment is in line with the openness of the internal market in the Union, and with the principle of freedom of establishment. Indeed it does not prohibit, for example, a foreign brewer selling, or even brewing, a beer in Germany, with an intense sweetener, or with any other additive authorized for beer in the Union.

One of the consequences of the amendment was that a list of traditional foodstuffs had to be drawn up, as it has proved impossible to define precisely what ‘‘traditional’’ really is. This compromise showed that many member states are reluctant to give up their protectionist habits. Indeed, a considerable number of products were proposed to the Com- mission for exemption from the horizontal rules on additives. Most of these were turned down on objective grounds by the Commission. The list of foodstuffs, with the additives which are banned, has been published as a Decision of the EP and the Council (34), and is presented in Table 4.

A basic remark to be made in this context is that such prohibiting legislation is not at all necessary. Indeed, the authorization of an additive does not make its use mandatory. And the ingredient list allows consumers to choose what they prefer. If there is commer- cially that much mileage in ‘‘brewed according to the Reinheitsgebot’’ and similar claims, market forces will provide the customer with such foods. A proper claim on the label would do better to achieve this than prohibitive legislation.

Table 4 Products for Which the Member States Concerned May Maintain the Prohibition of Certain Categories of Additives

Member Categories of additives which may state

continue to be banned Germany

Foodstuffs

Traditional German beer (‘‘Bier nach All except propellant gases deutschem Reinheitsgebot gebraut ’’) Greece

Feta

All

France Traditional French bread

All

France Traditional French preserved truffles

All

France Traditional French preserved snails

All

France Traditional French goose and duck pre-

All

serves (‘‘confit’’) Austria

Traditional Austrian ‘‘Bergka¨se’’ All except preservatives Finland

Traditional Finnish ‘‘Ma¨mmi’’ All except preservatives Sweden

Traditional Swedish and Finnish fruit

Colors

Finland syrups Denmark

Traditional Danish ‘‘Kødboller’’ Preservatives and colors Denmark

Traditional Danish ‘‘Leverpostej’’ Preservatives (other than sorbic acid)

and colors

Spain Traditional Spanish ‘‘Lomo embu- All except preservatives and antioxi- chado ’’

dants

Italy Traditional Italian ‘‘Salame cacciatore’’ All except preservatives, antioxidants, flavor enhancers, and packaging gas Italy

Traditional Italian ‘‘Mortadella’’ All except preservatives, antioxidants, pH-adjusting agents, flavor enhancers, stabilizers, and packaging gas

Italy Traditional Italian ‘‘Cotechino e zam- All except preservatives, antioxidants, pone ’’

pH-adjusting agents, flavor enhancers, stabilizers, and packaging gas

Source : Ref. 34.

J. Use Levels

Caution is to be applied in the interpretation of the maximum use levels given in the Directives. The general rule in the Directives is that the use levels authorized apply to the foodstuffs after preparation according to the manufacturers instructions.

In both the sweeteners Directive (27), Art 2 § 4, and the colors Directive (28), Art.

2 § 6, that is the case. In the miscellaneous Directive the same is also true for the additives listed in Annex IV. In the same Directive, Annex III might be subject to the same rule, if the notes at the bottom of page 16 in the Official Journal refer to the whole of Annex

III. If that note applies only to Part A of Annex III (sorbates and benzoates), it would follow that Parts B (sulfites), C (other preservatives), and D (other antioxidants) fall under the rule for miscellaneous additives, which is expressed in Art. 2 § 7 of that Directive (10). That rule is that the quantities apply to the foodstuff as marketed. Which of the two interpretations is to prevail remains open until an official clarification is given.

For nitrites and nitrates, residual amounts are mentioned, rather than ingoing amounts, although some indicative ingoing amounts for nitrites are mentioned as well. Although the Directive on miscellaneous additives does not mention it, similar con- siderations might apply (e.g., for antioxidants), for which, at least in principle, the entirely of the amount added might not be found in the finished product.

The official control will normally run its checks on analysis figures (residual amounts), rather than on recipe figures (ingoing amounts). The two may sometimes differ.

The case of sulfites merits special citation. Sulfites are controversial as additives. The miscellaneous additives Directive indicates that the levels authorized ‘‘. . . relate to the total quantity, available from all sources,’’ (i.e., the sum of natural presence, added as an additive, added as a processing aid, from ‘‘carry-over,’’ spontaneously created in the manufacturing process, etc.). Still the same text stipulates that a quantity of 10 mg/ kg or mg/L is considered as not present. This arbitrary analytical borderline is laid down in a Directive authorizing additives (p. 19 in Ref. 10). Hence the statement cannot bear on labeling. For example, one can imagine a case where 15 mg/kg of sulfite arises by carry-over in a complex foodstuff without technological effect in the final foodstuff. Al- though it is analytically present, it would not need to be labeled since it is present merely by carry-over (see also Sections V.E and V.N). However, in all likelihood legislation on the labeling for intolerance-causing agents in preparation in the EU may make the labeling of 10 mg/kg (or mg/L) of sulfite, or more, compulsory anyhow.

For colors the maximum use levels indicated in the Directive refer to the ‘‘coloring principle ’’ (as examined by the SCF), rather than to the formulated preparation as a whole.

K. Quantum Satis

For a number of authorizations, the regulators have accepted a concept from Belgian law: Quantum Satis (QS). This means that ‘‘. . . no maximum level is specified. However additives shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer.’’ The notion is defined in Art. 2 § 8 of the miscellaneous Directive (10) and identically in Art. 2 § 7 of the colors Directive (28). Remarkably, QS is also used, but not defined, in the sweeteners Directive. There is no doubt that this same interpre- tation is to be applied there.

Before the concept of QS was introduced, the same was expressed regularly with the term good manufacturing practice (GMP) (as in Codex). Quantum Satis is, as a rule, used for additives for which the SCF has set a non- numerical ADI. But this is not true across the board. In certain self-limiting applications, additives with numerical ADIs are authorized under QS. An example is karaya gum (which has an ADI of only 12.5 mg/kg body weight, but the authorization at QS is given only for the low volume dietary supplements in the miscellaneous Directive (10, p. 28). Tartaric acid (E334) is authorized at QS (Annex I of Ref. 10), yet the ADI is 30 mg/kg body weight.

Conversely, there are additives for which the ADI is NS (i.e., the non-numerical ADI not specified), yet the authorizations given are not QS [an example is propionic acid in bread, where German opposition may have been the main political reason to limit the quantity in the miscellaneous Directive (10, p. 24)]. For a similarly non-numerical ADI

A (acceptable), there are cases where QS has not been allowed. [An example is thaumatin in confectionery. See the sweeteners Directive (27) p. 11].

L. Additives Authorized and/or Restricted for Foods for Particular Nutritional Uses

The additives for foods for particular nutritional uses are to be found in the tables of the regular additives Directives.

Also additives for infant foods, weaning foods (follow-on formulae), and foods for babies are regulated by the the regular additives Directives.* However, it should be noted that neither sweeteners (see in Section VII.A.1) nor colors (see in Section VII.B.1.a) are permitted in foods for infants and in weaning foods. So, authorizations for additives in these foodstuffs can only be found in the miscellaneous additives Directive (see in Section VII.C.3).

M. Intake Surveys

In each of the three additives Directives—on sweeteners (Art. 8 of Ref. 27), on colors (Art. 15 of Ref. 28), and on miscellaneous additives (Art. 7 of Ref. 10)—the EP obtained the insertion of an amendment imposing surveys on additive intake. The basic motivation behind this request is expressed only in the sweeteners Directive (27). It somehow trans- lates distrust and fear of the safety of additive usage as authorized. Yet such surveys may bring real benefits.

Although the request to run the surveys on additive intake is addressed to the mem- ber states, it is the European Commission which has to report to the Parliament within five years of adoption of the sweeteners Directive (i.e., before June 30, 1999), or of the enactment of the colors and miscellaneous additives Directives (December 31, 2000, and September 25, 2001, respectively).

It is likely that updating Directives on food additive authorizations will be issued after 1999, when the results of the surveys have been evaluated.

* In Directive 91/321/EEC it was announced that a Directive would be issued, authorizing additives for

1. Industry Perceptions on Additive Intake The vast majority of data available suggest that for most additives the real intake represents

a far less important part of the ADI than is generally thought. Moreover, there is no harm in going beyond the ADI on certain days. The ADI is a guideline limit, only not to be exceeded every day in a lifetime. Furthermore, many additives which are authorized in certain foods are not always all present, or present up to the maximum level permitted, or present in all the brands of foodstuffs for which they are permissible. Hence, it should

be evident that, across the board, additive usage is far lower than would be believed upon straight extrapolation from the legislation. In many cases the ADI was set at a rather low level (e.g., the case of annatto or nisin). This is not because adverse effects were observed in the toxicological tests, but rather because the tests have not been extended to include sufficiently high intake levels.

Industry is caught in a double bind on the matter of intake surveys. If it contributes, even only in offering information, its contribution may well be used to justify cutting additive authorizations. If it does not contribute, the unreliability of the data that might

be put forward by the authorities might lead to wild overestimates of consumption, and hence to authorization cuts anyhow. In the first case, industry’s contribution might, for example, establish that far fewer, or lesser amounts of, additives are being applied than are now authorized. This might be an excellent ground for legislators to contest many a case of need, and consequently to trim authorizations to less kinds of additives, or to ‘‘more realistic’’ levels. Of course, acceptance of such a cutback scenario would make a mockery of past concentrations and would be disastrous for innovation.

In the exercise, it is evident that industry cannot be only an interested bystander. CIAA, for example, has expressed its views. These are, amongst others, that (1) it is willing to contribute to data collection, (2) it encourages participation at national level and in the context of the system of scientific cooperation between the member states, and (3) it wants to know the specific objectives and the nature, as well as the format, of the data sought.

2. Scope of the Intake Surveys Crossing 365 additives with thousands of foodstuffs creates a staggering number of cells.

The enormity of the undertaking, to fill possibly millions of cells, requires gross simplifi- cation to make the task manageable. The problem of cost is not a minor one either.

The SCF, as well as outsiders, are being consulted on the best methods of ap- proaching the matter. The European Commission has looked for support (information and funds) from industry.

Even if data are collected nationally—exploiting to the maximum the systems al- ready in use for that purpose in the member states—it is necessary to work at the European level to establish uniform operating principles and coordination, and to consolidate the results in a database.

3. First Steps in Additive Surveys Not all additives require evaluation in detail. The European Commission, on the basis of

a preliminary study, adopted a decision tree approach as a risk assessment tool. Using essentially the Danish budget method (36), a list has been established of additives for which further evaluation of the consumption might be required. It includes, amongst oth-

The occurrence of an additive in that list does not necessarily mean that the intake of that additive is too high. It may very well mean that the Danish budget method is not perfect for risk assessment in that case. Further studies and deliberations are ongoing.

4. Value of Surveying Additives Now The new additives legislation did, no doubt, change additive usage in the EU. Hence, it

can be foreseen that intake studies run during the first years after adoption of the new additives legislation, as requested by the EP, may not yield results relevant for the past as well as for the coming years. Running such studies now is like trying to pinpoint a moving target.

N. Carry-Over: Two Kinds

The principle of carry-over also authorizes in compound foodstuffs those additives, in the quantities which are authorized, in their constituent ingredients.* On the other hand,

a principle termed reverse carry-over authorizes the use of additives which are permitted in a final compound foodstuff, also in the (intermediate) ingredients to be used in such a compound foodstuff. The condition for the application of the principle of this reverse carry-over is that the (intermediate) ingredients shall not be for direct consumption. The quantities permitted in the (intermediate) ingredient have to be adjusted to produce a lawful level in the final compound foodstuff.†

It should be clearly understood that carry-over relates to the authorization for use of an additive, not to its labeling. An additive introduced according to reverse carry-over is of course to be labeled, since it will necessarily be functional in the final product. On the other hand, an additive which is present in a compound foodstuff can be either func- tional or not. The functionality of such an additive decides whether labeling is triggered; additives which are functional in the end product are to be labeled. In general, if the additive in the end product is no longer functional, it need not be labeled (see also Section V.J). Note however that additives when used in a compound ingredient (e.g., in the choco- late coating of a cereal bar) must be declared in the ingredient list (see also Section VI.A)

Both the carry-over principles are expressed only in the Directives on colors (28) and on miscellaneous additives (10). Industry has asked that the principle should be gener- alized to include sweeteners as well. It was hoped that this would be granted in the context of an amendment to the sweeteners Directive. Some of that has materialized; however, the amending Directive (25) has severely restricted reverse carry-over for sweeteners (see Section VII.A.7).

In each of the Directives with clauses on carry-over (10,25,28) exceptions on autho- rization to use clauses on carry-over are indicated. Each of these are discussed in sections on the specific Directives (see Section VII).

* An example: fruit-based pie fillings may contain up to 100 mg of sulfites per kilogram of filling. Although there is no specific authorization for sulfite in pies, the pies prepared with such fillings may contain all the sulfite introduced with such fillings. Assuming that only one-third of the pie is filling, the total pie may not contain more than 33.3 mg of sulfite per kilogram of pie.

† An example: annatto is authorized in extruded or expanded snacks, up to 20 mg per kilogram of snack. Although annatto is not an authorized color for seasonings sold to the final consumer, seasonings destined for flavoring these snacks may contain up to 200 mg of annatto per kilogram of seasoning, if the seasoning constitutes

O. Enriched Preparations: Coloring Foods

Only the colors Directive (28) insists that the isolation of a constituent of regular food, resulting in an enriched preparation with a distinct and strengthened technological effect, changes the resulting preparation into an additive, to be authorized, labeled, etc. It might

be that the same principle could, in the long run, come to prevail for all other additive types as well: for sweetening preparations (such as liquorice or Stevia*) flavor enhancing properties (such as yeast extract), or antioxidant preparations (such as rosemary extract).

The consequences for business of these stipulations are far-reaching. There has been, in the past, a widespread practice of using extracts from flowers and foodstuffs as coloring agents, for example, in Germany and in France. The Directive on colors prohibits this practice, unless these preparations are defined, receive an official safety clearance from the SCF. According to the letter of the Directive, only when the coloring effect of prepara- tions made from foodstuffs is secondary to a dominant property of taste, sapidity, or nutri- tional effect will an exception to this rule be accepted (such as for paprika, turmeric, and saffron).

A particularly important example of a coloring foodstuff is malt extract. Industry has argued forcefully in favor of considering malt extract as a food in most applications. The Standing Committee for Foodstuffs has, based on past history of use as a food, accepted Hibiscus (rosebud) as a food which can be used for coloring purposes. Several other of such preparations remain problematic however.

It is obvious that this is a gray area, inviting dispute. The clarifications and decisions made, on a case by case basis, by the official control in individual member states will remain very important in these matters.

P. Natural Occurrence

Only for sulfites is there a statement in the miscellaneous Directive (10) stating that the maximum values include sulfite from all sources. For none of the other additives is such

a clarification given. Still the same Directive acknowledges that nisin, benzoates, and propionates may be produced in fermentation processes, and thus be present without will- ful addition.

But substances classified as additives can also be present in foodstuffs without being added, and without being generated by fermentation. Phosphates are naturally present in important quantities in milk, for example. (Other mineral salts come in the same category in various foodstuffs.)

To date there is no general statement in the additives Directives stating that natural compounds present are not included in the maximum use levels for the additives, and that these levels refer merely to the quantities added. Such a statement is desirable. Indeed, it is disturbing that in dairy products, for example, the phosphates present naturally can exceed the maximum levels authorized for addition as additives.

* Stevioside, a sweetening substance derived from Stevia, has not been authorized as a sweetener in the EU, as no acceptable toxicological data were yet submitted to the SCF. With the high sweetening power of stevioside preparations, it is hard to imagine how such preparations could be considered foods (nutrient properties negligible compared to the sweetening power). Glycerrhizin, a sweetening substance present in liquorice, is not