LABELING OF ADDITIVES

VI. LABELING OF ADDITIVES

A. Requirements

Additives are ingredients. Article 6 of the general labeling Directive (18) makes labeling of their use compulsory in an ingredient list. There are however some exemptions; the most notable one being drinks with an alcohol content of more than 1.2%. So far, these need not carry ingredient labeling (Art. 6 of Ref. 18). Consequently alcohol-free beers routinely carry a list of ingredients. A proposal of the Commission is now being developed in order to generalize the requirement for labeling of ingredients to all alcoholic drinks (37). It is the author’s perception that enactment of such a measure in the EU is several years off due to the procedural problems.

It seems evident that substances which are sometimes being used as additives, but which may also be produced as byproducts in the manufacturing process, need not be labeled as ingredients either, since they have not been added intentionally (e.g., in fermen- tation: benzoates, propionates, sulfites; see Section V.P).

In the same way, additives whose presence in a foodstuff is merely due to carry- over (see Sections V.J and V.N) and which have no technological function in the final foodstuff need not be indicated in the ingredient list [Art. 6 § 4.(c).ii of Ref. 18].

Furthermore, additives used as processing aids need not be indicated in the ingredi- ents list [Art. 6 § 4.(c).ii of Ref. 18] since processing aids are not to be considered as ingredients. Similarly, ‘‘solvents’’ or ‘‘media’’ for additives or for flavoring need not be labeled either [Art. 6 § 4.(c).ii of Ref. 18].

Additives in the ingredient list must be preceded by the name of their additive label- ing category (i.e., their function), as laid down in Table 4 (from Annex II of 93/102/EC) (38). If a substance exerts more than one function, it is the principal function that should

be indicated. Additional special labeling requirements for certain categories of additives are pre- sented in Section VI.E. See also Sections VII.A.4 (sweeteners) and VII.B.4 (colors). There is a rule on labeling—contested nowadays—which exempts from indicating the individual components of compound ingredients in the ingredient list when they total less than 25% of the finished food. (Art. 6 § 7 of Ref. 18). However, all additives must

be separately labeled; the 25% rule on ingredients does not apply to additives. An EU Commission Directive is in the pipeline to make mandatory the indication on the label of prepackaged foods of agents causing severe adverse reactions (32). As stated, the only additives considered in this respect are the sulfites (ⱖ10 mg/kg).

Irrespective whether it is for the purpose of intolerance warnings (32) or for ingredi- ent listing (10), sulfites are considered not present when their total quantity from all sources does not reach 10 mg/kg.

B. Additives Names

The additives must be designated by their specific name or by their E number. The E number is a number officially assigned by the EU (see Section III.F). The numbering is established by the publication of the Directives authorizing their use in foodstuffs. (It should be noted in this respect that E numbers have been created longer ago than the INS numbers of Codex Alimentarius).

Both in the E numbering system and in the INS, complementary lower case specifiers Both in the E numbering system and in the INS, complementary lower case specifiers

Examples of the first kind are the diphosphates: E450 i through vii (10). Examples of the second kind are E407 (carrageenan) (10) and E407a (alternatively refined carra- geenan) (24).

As to the specific name to be used, it seems reasonable to assume that, in addition to the names used in the Directives, generally accepted synonyms can also be used. No doubt synonyms listed in the official specifications of the EU and of JECFA are to be considered ‘‘generally accepted’’ and understood. They could hardly be considered misleading. Still, it may remain controversial for some time to come as to whether all these synonyms— rather than only the exact Directive designations for the additives—are to be used. It is clear however that commercial trade names are not acceptable for use in ingredient lists.

At the time of this writing, industry is active in proposing to allow the use of simpli- fied names for the additives. The E numbers have carried an unpleasant stigma since the infamous ‘‘Tract de Villejuif ’’ (see Section III.F), and the Directive designations some- times sound awfully long and chemical. It is to be hoped that the authorities will authorize simplifications in order to enhance the transparency of the labels. Deliberations among the member states on the matters do not seem promising in this respect.

C. Order of Indication

The ingredients must be listed in the ingredient list in descending order of their weight at the mixing bowl stage [Art. 6. § 5(a) of Ref. 18]. Additives may therefore often occur in several positions, interspersed amongst other additive and nonadditive ingredients. In cases where several different additives with the same function/category occur in the same foodstuff, the ingredient list will have to mention several times (and at different positions in the ingredient list) that same function/category indication, followed by the name of the different additives. All this may make the ingredient list quite unwieldy.

The list of the function/categories to be use in labeling are given in Table 2 . As already indicated, it differs only slightly from the one in Table 1 (which refers only to authorization). In labeling, the functions ‘‘sequestrant,’’ ‘‘enzyme,’’ and ‘‘packaging gas’’ (occurring in Table 1, but not in Table 2) do not have to be indicated in the ingredient list with the names of the substances added to a food. See Section VI.E.1, however, for detail on the obligation to indicate on the label when packaging gases are being used.

D. Quantitative Ingredient Declaration

The quantity of any ingredient in a foodstuff which is emphasized on the label (by name, picture, or claim)—including additives—must be indicated, either in the ingredient list or next to the sales descriptor on the label (39). The percentage indication must show (with some exceptions) the quantities at the mixing bowl stage during manufacturing. In some specific cases, this obligation is waived (40).

tol ’’ on a special banner on a chewing gum. However, cases where sweetener(s), or sweet- ener(s) and sugar(s), are to be ‘‘double labeled’’ merely because the law requires so (see Section VI.E.3) do not trigger QUID (40).

E. Labeling Warnings for Specific Additives

For certain additive categories, the legislators have considered that the mere indication in the ingredient list does not sufficiently inform the consumer, specifically, for packaging gases and sweeteners.

1. Packaging Gases In an amendment (41) to the labeling Directive, the application of the special statement

‘‘packaged in a protective atmosphere’’ to all ‘‘. . . foodstuffs whose durability has been extended by means of packaging gases . . .’’ was imposed. No detail is given on how (font size or color, e.g.) and where exactly this indication is to be put on the label.

2. Tabletop Sweeteners Tabletop sweeteners are not foods, but additives sold directly to the ultimate consumer

(see Section VII.A.1.c). The sweeteners Directive (27) requires that tabletop sweeteners (just like foodstuffs; see Section VI.E.3) containing more than 10% of polyol bear a warn- ing for laxative effect: ‘‘excessive consumption may induce laxative effects.’’ The dose at which such effects may occur need not be referred to. For tabletop sweeteners which contain aspartame, also the indication ‘‘contains a source of phenylalanine’’ is required (see also in Section VI.E.4 for aspartame).

For none of these additional labeling particulars is the size or presentation of the letters explicitly laid down by the text. The general warning for laxative effect of a tabletop sweetener, without reference to the absolute amount of polyol ingested, seems strange. Indeed, such products are essen- tially made of intense sweetener, whilst the polyol ingested constitutes a very small amount of excipient. Only a large amount of polyol can trigger laxation.

3. Foodstuffs Containing Sweeteners The sweeteners Directive (27) requires also for foodstuffs containing more than 10% of

polyol, as for similar tabletop sweeteners, that they bear the same warning for laxative effect: ‘‘excessive consumption may induce laxative effects.’’

Similarly, for foodstuffs which contain aspartame, the indication ‘‘contains a source of phenylalanine ’’ is required as well. Certain associations of people suffering from phen- ylketonuria (PKU) quite logically declared that mentioning aspartame in the ingredient list was sufficient for them.

Furthermore, an additional special measure imposes a ‘‘double’’ indication that sweeteners are being employed in a foodstuff (42).* The same text also imposes such an

* The sweeteners Directive announced the adoption, before the end of 1995 and according to a precise procedure laid down in the sweeteners Directive (27), of provisions which would spell out ‘‘the details which must appear on the labeling of foodstuffs containing sweeteners in order to make their presence clear ’’ and ‘‘warnings concerning the presence of certain sweeteners in foodstuffs’’ (meaning again aspartame for its phenyl- alanine content and the polyols for their laxative effect in case of abuse).

That procedure would normally have led to a Commission Directive. Such a Commission Directive That procedure would normally have led to a Commission Directive. Such a Commission Directive

This ‘‘double labeling’’ legislation has been strongly opposed by industry, since it means that certain additives would have to be indicated twice on the label. People at special risk can consult the ingredient list, which is provided exactly for that purpose. Furthermore, the principle of double labeling of only certain ingredients seems grossly unfair; it suggests risks inherent in sweeteners which are nonexistent or disproportionate. It also sets a precedent. Why would colors or preservatives not have to be similarly double labeled in the future? Hence, it should be realized that the measures imposed neither address real risks nor sufficiently address real but concealed risks inherent to other kinds of ingredients, such as, for example, sugar in regular foods without sweeteners with refer- ence to caries or to diabetes. Some further comments on this issue as related to additive function are given in Section VII.C.1.

4. Aspartame-Sweetened Foodstuffs

A far more serious objection to a generalized special double labeling for aspartame con- cerns its misleading effect on the real people concerned. Normal advice to people suffering from PKU, who ought to avoid aspartame and for whom the special warning is meant, is to shy away from foods that contain copious amounts of phenylalanine—eggs, milk, meats, etc. Although the tolerance is personal, a rule of thumb for a PKU patient is to stay below 20 mg of total phenylalanine intake per kilogram body weight per day. But even PKU sufferers need an essential minimum of 300 mg of total phenylalanine per day.

What is the contribution of aspartame to the burden of, for example, a snack product? Assume a child of 20 kg suffering from PKU. The child should avoid phenylalanine in excess of 400 mg per day. The sweeteners Directive allows snack products to contain up to 25 mg of aspartame per 50 g of product. This is equivalent to 14 mg of phenylalanine. This is between 9 and 0.9% of the phenylalanine burden of the same product without aspartame. This means that the relative importance of the aspartame addition is not very significant. It is indeed not the added aspartame which will be the important burden; the snack food itself is the vastly more important burden which should be avoided by the rare PKU sufferer.

PKU patients clearly know how to avoid basic foods containing a lot of protein, such as steak, eggs, cheese, etc. For a variety of transformed, processed, and packaged foodstuffs, however, such knowledge may be more difficult to get without information from the label, from the manufacturer, or from their PKU associations.

rejection of the proposal by the Standing Committee for Foodstuffs (SCF) the proposal was finally adopted by the Council, leading to a Council Directive.

Most of the more recent Directives, adopted to complete the internal market, have been adopted as ‘‘EP and Council Directives .’’ In principle, the deadline of the end of 1995 for these special labeling measures for sweeteners has not

Hence, if for example a sweet-sour seafood in a jar whose phenylalanine level is slightly increased due to the presence of aspartame is labeled as ‘‘contains a source of phenylalanine ,’’ PKU patients may be lulled into believing that such seafood products that do not contain aspartame are not sources of phenylalanine. And this is plainly a counterproductive kind of disinformation. It coaches PKU patients into making their own decisions in such matters and away from the more reliable sources of information (such as for example their associations’ databases). Thus, the label, as the European Commission document intends to complete it, is not at all the appropriate vehicle to provide the rare PKU sufferers with the sufficiently detailed information they need.

5. Adverse Reaction and Allergen Warnings This subject is discussed above in Section IV.E.

F. GMO-Derived Additives

As stated in Section II.E.6 GMO-derived additives are not regulated by the novel foods Regulation (9). A Regulation on the labeling of GMO-derived maize and soya products was issued insofar as these are foods only (43).

Although there is strong pressure on the legislators to also impose the indication of the GMO origin of additives on the label, this raises a number of difficult problems. A proposal for such legislation is circulating anyhow at the time this manuscript goes to press. It might be finalized and issued by the end of 1999 or in the year 2000.