THE SPECIFIC EUROPEAN DIRECTIVES ON ADDITIVES

VII. THE SPECIFIC EUROPEAN DIRECTIVES ON ADDITIVES

The additives legislation for the EU has been split essentially into three parts: sweeteners, colors, and all the others (or miscellaneous additives). The full texts of the Directives, as published in the OJ, is available on diskette from the author of this chapter (see Section X.1).

The legislators’ aim is to consolidate, at a later stage, all these Directives into one global food additives Directive. Neither planning date nor precise format for this future consolidation are known at present. As all Directives are to be transposed in national law anyhow, a consolidated version is no high priority.

In Appendix Tables 1 and 2 all EU authorized additives have been listed with their ADIs, as well as with the page numbers where they occur in the Directives. The corre- sponding Directives have been indicated by SWET (sweeteners) (27), COLR (colors) (28) and MISC (miscellaneous additives) (5,10,24). In Appendix Table 1 the additives have been sorted by E number; in Appendix Table 2 they are put in alphabetical order. Authori- zations introduced in updating Directives have been indicated with UPM (miscellaneous additives) or UPS (sweeteners) in Appendix Tables 1 and 2.

The Directives were originally elaborated starting with sweeteners and colors. These two categories of additives were chosen to start the proceedings because public opinion is highly sensitive to them. Furthermore, as some member states were gearing up to issue their own legislation on sweeteners, it was logical for the European Commission to start

A. Sweeteners Directives

1. Structure, Authorizations, and Annexes After the first Directive on sweeteners (94/35/EC) (27), an updating Directive was issued

(96/21/EC) (25). The Directives on sweeteners each consist of a ‘‘legal part’’ and one Annex with tabulated authorizations.

A definition for sweeteners can be found in Art. 1 § 2 of 94/35/EC. Two kinds of sweeteners are authorized: bulk sweeteners, or polyols, and intense sweeteners. The bulk sweeteners have a relative sweetness per unit of mass similar to the sweetness of sugar. Intense sweeteners are many times sweeter. All the sweeteners authorized carry E numbers of the 900 series, except E420 (sorbitol) and E421 (mannitol).

In drafting the sweeteners Directive, the European Commission wanted to limit au- thorizations essentially to foodstuffs for which a clear consumer benefit and/or a techno- logical need was perceived: reduction of energy intake, manufacturing of noncariogenic and of dietetic foodstuffs, foodstuffs with no added sugar, or foodstuffs with increased shelf-life (prevention of microbial spoilage).

However, certain flavors of nonsweet snack foods, containing a quantity of intense sweeteners (for which sugars were not appropriate), but which did not satisfy the stated authorization criteria, were already on the market in at least two member states. This existing practice, properly highlighted to those responsible, has forced the hand of the legislators into accepting this additional criterion for authorization.

Sweeteners are prohibited in foods for infants and for young children (27; Art. 2 § 3).

A carry-over clause (see Section IV.N), missing in Directive 94/35/EC, is intro- duced for sweeteners in the update Directive (see Section VII.A.6).

a. The Polyols. The polyol authorizations in the two sweeteners Directives bear exclu- sively on their prime function: to sweeten foods. In addition to this function, polyols can also fulfill other technological functions, such as humectants, stabilizers, etc. For these last functions, the authorizations are regulated by two miscellaneous additives Directives (see Section VII.C).

For polyols, authorizations in drinks were not granted out of concern for their laxa- tive effect in youngsters. Sweetener authorizations for polyols have not been granted for all solid foods. Instead, a positive list was imposed. This will, of course, limit potential new applications, unless additional authorizations are obtained. And that is a long and difficult process.

In the sweeteners (27) and in the miscellaneous additives Directives (5,10) the autho- rizations for polyols are given up to a level of Quantum Satis. The polyols for which authorizations have been given are sorbitol, mannitol, isomalt, maltitol, lactitol, and xyli- tol. For uses authorized under miscellaneous additives, the labeling should not indicate ‘‘sweetener’’ as the function. The real function—such as, e.g., ‘‘humectant’’—should precede the name of the polyol.

b. Intense Sweeteners. Authorizations for six intense sweeteners are given in two Di- rectives on sweeteners (25,27): acesulfame K, aspartame, the cyclamates, saccharin and its salts, thaumatin, and neohesperidine dihydrochalcone (or NHDC). See Table 5 (see also footnote in Section V.O.). So far, sucralose and alitame are not authorized in the EU.

Considerable opposition has been voiced against cyclamate by France and the UK

ADI. The EU Commission has steadfastly defended the position taken by the SCF in that respect (44). In 1995, This body first reconfirmed a temporary ADI of 0–11 mg/kg body weight for the cyclamates, pending new data. The cyclamates were up for revision by the SCF before June 30, 1999 (45). In March, 2000, a new ADI of 7 mg/kg body weight was set.

For some intense sweeteners some other technological applications have also been authorized as flavor enhancers in the miscellaneous additives Directives (5,10). For use in certain desserts, soft drinks, and chewing gums these are acesulfame K, aspartame, thaumatin, and NHDC. NHDC is furthermore also authorized—below its sweetness threshold level—in margarine, spreadable fats, meat products, fruit jellies, and in vegeta- ble proteins.

Again, in these cases the intense sweeteners should be labeled with their real func- tion, that is, as ‘‘flavor enhancers’’ and can, in principle, do without warning labeling (see Section VII.C.1).

c. Tabletop Sweeteners. In the emerging EU additives legislation tabletop sweeteners are not considered foodstuffs. They are additives sold as such to the final consumer. In tabletop sweeteners, and other sweeteners sold directly to the consumer, only the same sweeteners are authorized as those authorized in regular foods (i.e., those occurring in the Annexes of Ref. 27).

d. Food Descriptors and Format. Most of the food descriptors used in the sweeteners Directives are uniform, that is, terms used for a food descriptor are the same each time, irrespective of the specific sweetener. This fact makes possible to list the authorizations of intense sweeteners in an easy orientation table (see Table 5 ).

In fact, this similarity in terms used for the descriptors is somewhat misleading, as it might suggest that all sweeteners received all the same authorizations. This is not the case; there are small differences. Table 5 should be consulted with reference to the pub- lished Directives in order to know precisely which authorizations are applicable for each sweetener.

In the published form, the subtitles and the layout in the Annexes of the Directives are somewhat unfortunate as, for example, beers and sauces have come under ‘‘confec- tionery .’’

2. ‘‘No Added Sugar’’ Directive 94/35/EC (27) defines ‘‘with no added sugar’’ as ‘‘without any added mono-

or disaccharides or any other foodstuff used for its sweetening properties .’’ Indeed, food- stuffs with sweetening properties, such as honey, as a rule hold plenty of mono- and disaccharides. By and large these compounds have properties very similar to these of regular sugar (caloric effect, cariogenicity, general physiological properties, glycaemic index, etc.). Hence someone wishing to avoid regular sugar is generally well advised to avoid such sweetening foods and mono- and disaccharides as well.

3. ‘‘Energy Reduced’’ Similarly, ‘‘energy reduced’’ is defined in the same text as ‘‘with an energy value reduced

by at least 30% compared with a similar foodstuff or a similar product .’’ The ‘‘energy reduced ’’ claim is very important. The definition of the term in the sweeteners Directive is relevant only for the addition of sweeteners to foods. It does not pertain to labeling.

the energy reduced claims in labeling may be different from member state to member state. The stakes on the definition of this claim are high. Dietary significance should prevail.

Although claims should have been regulated in the Directive on labeling claims, it was decided to issue a ruling on energy reduction in the sweeteners Directive. Although the motive to do so is obviously the desire to give the sweeteners Directive a clear meaning, the decision is quite unfortunate as will be explained. The text of the Directive defines energy reduced foods as having at least 30% reduction in calories in comparison to the original product or a similar product.

With some exceptions, the sweeteners Directives restrict the use of sweeteners to foods that do not contain added sugar or that are energy reduced. In the opinion of the legislators, these conditions should help limit sweetener intake. The main motive in impos- ing a 30% minimum energy reduction is the wish to respect national practice and existing food standards. But it may be thought, at first, that a more stringent definition of energy reduced (i.e., 30% instead of 25%) would further restrict consumer exposure to sweeteners. Close examination of the case reveals that this is not so. At least 90% of the sweetener intake stems from the consumption of tabletop sweeteners, essentially calorie-free soft drinks and yogurt with 0% fat. Since in these products a calorie reduction of 30% or more is easily achieved, the main sources of sweetener intake are not affected by this legislation. As for the remaining 10% of products, which earlier had been reduced in calories by less than 30%, such as marzipan in Germany, the new legislation will require the substitution of a bigger share of sugars by intense sweeteners and thereby increase sweetener intake. Some other products, such as certain fine bakery wares, may not be manufactured because

a 30% reduction of calories cannot be achieved. On balance, sweetener intake will there- fore not be diminished. The application of the 30% limit therefore does not fulfil its in- tended purpose.

Furthermore, if it is accepted that the incorporation of a 30% value in the sweeteners Directive will lead sooner or later to the adoption of an identical value in national or European regulations on food labeling or claims; the nutritional implications for the con- sumer must already be considered at this stage.

In this regard it must be noted that dietary guidelines issued by many European countries advise consumers to reduce their fat intake and to control their calorie intake so as to avoid obesity and being overweight. It is clear that calorie-reduced foods play an increasingly important role in the consumer’s attempt to reach these dietary goals.

Although the food industry would like to meet the consumer’s demand for calorie- reduced foods, it is often difficult (for food technological reasons) to reduce the calorie content by more than 20–25% without affecting the taste and texture of the product in an unacceptable way. If the consumer is to be offered a sufficiently wide choice of calorie- reduced good tasting foods, the definition of ‘‘calorie reduced’’ should not be made too stringent. Although it might at first appear that the consumer benefits more from a 30% limit than from a 25% limit for calorie-reduced foods, the reverse is true. In fact, a moder- ate 25% reduction of calories in a wide range of good tasting foodstuffs will facilitate compliance with dietary objectives, while a more ambitious 30% reduction of calories will inevitably result in a smaller number of less attractive taste-wise calorie-reduced foods.

This opinion was also shared by the Codex Committee on Nutrition and Foods for Special Dietary Uses, which at their 1989 meeting noted that calorie reductions of as high as 30% were not always feasible, and which therefore recommended a minimum reduction of 25% in calories (46). It is significant to note that this Codex recommendation was

Although seemingly moderate, a 25% reduction in calories is nutritionally significant if it is maintained. Consequently, the established Codex standard for nutrition claims requires an energy reduction of at least 25% for allowing a reduced energy claim.

Thus any future decisions on this matter of reduced energy clearly constitute a poten- tial threat not only to industry’s, but also to consumers’ best interests.

A number of foodstuffs are rich in energy even if sugar is not added (for example, by the presence of fats and starch). It follows that the legislators have not authorized sweeteners for such foods. In this way, no usage of sweeteners was granted for regular fine bakery ware. However, for such bakery ware destined for particular nutritional uses (dietetic, etc.), certain sweeteners were authorized.

In authorizing sweeteners for ‘‘cocoa-(based) confectionery, energy reduced or with no added sugar ’’ in a horizontal rule (27), the legislators had to solve a conflict with the vertical one (3), which requires sugar as the sweetener for chocolate. A solution was agreed to the extent that ‘‘energy reduced chocolate’’ or ‘‘chocolate with no added sugar’’ would be considered outside the scope of the chocolate Directive (as far as authorization of additives is concerned; this is not necessarily the case for labeling). Certain member states, such as Denmark, have recently contested this approach. Other member states, however, such as Belgium, are endorsing it. Note in this context that an updated vertical EU Directive on cocoa and chocolate products is in the pipeline, but has not yet been adopted at the time when this paper goes to press.

4. Labeling for Sweeteners This issue has been discussed in depth in Sections VI.E.2, 3, and 4. Also as highlighted

in Sections VII.A.1.a and .b, substances typically known as sweeteners can have nonsweet- ener functions as well. Such applications have been granted in the miscellaneous Directive (cf. Section VII.C.1).

5. Mixtures of Sweeteners In establishing the conditions of use, and as recommended by the SCF, the European

Commission has trimmed maximum levels of the individual sweeteners on purpose so as to push manufacturers to apply mixtures of different sweeteners instead of using more single sweeteners. This way, there is a lesser chance of exceeding the ADI for individual sweeteners. Of course this entails additional complications on the label.

All sweeteners (intense and bulk sweeteners) may be used in combination, up to their maximum use levels, also in mixtures with sugars.

6. Update of the Sweeteners Directive As Directive 94/35/EC was being finalized and adopted, it became clear that an amending

update was desirable. Such a Directive—96/83/EC—was issued mainly in order to en- courage technical developments (25). The new Directive renames the food descriptor ‘‘Vi- tamins and dietary preparations ’’ to ‘‘Food supplements/diet integrators (e.g., vitamins, trace elements), syrup-type or chewable .’’ In fact this is not a mere renaming (that is, another descriptor for the same foods), but rather a redefinition of the meaning of the food category.

The new text introduces the QS principle. It also introduces the two carry-over clauses for sweeteners as well, except for food supplements/diet integrators. Amazingly The new text introduces the QS principle. It also introduces the two carry-over clauses for sweeteners as well, except for food supplements/diet integrators. Amazingly

In addition, in the Annex some 40-odd new authorizations are given, all for the same intense sweeteners as were found in the original sweeteners Directive (27). These newly proposed authorizations have been indicated with ‘‘UPS’’ in Appendix Tables 1

and 2 . The Annex of the update Directive draft also introduces, for saccharin and for the

cyclamates, notes which state that the quantities are to be expressed as free imide or acid, respectively. This is a worthwhile clarification since it removes ambiguity from the tables. It should be realized that these notes increase the levels of the sweetener anions saccharin and cyclamates which can be used by 12% (sodium) to 22% (calcium). Note that saccharin potassium salt can be used as well in a similar way. As acesulfame K is only being com- mercialized in the potassium form, the same rule has not been made applicable to that substance.

7. Implementation All member states should have already adapted their national legislation so as to bring it

in compliance with the two Directives on sweeteners. They are already obliged to grant free circulation to products complying with the two Directives, and noncomplying prod- ucts are already banned from all of the EU market as well.

8. Specifications For sweeteners, the European Commission has published the specifications for all author-

ized sweeteners in a Directive (19).

B. Colors Directive

1. Structure, Authorizations, and Annexes The Directive on colors deals with additives with a clear function. Only two closely related

additives are common to both the colors Directive (28) and the miscellaneous additives Directive (10). These are calcium carbonate and calcium hydrogen carbonate (E170 i and

ii, respectively). When the calcium carbonates are used in noncoloring functions, they should obviously be labeled in their real function; such as, for example, ‘‘acidity regu- lator .’’

The Directive on colors (28) comprises a legal part as well as five Annexes. It has

a quite complex structure. It gives authorizations for 43 colors. These carry E numbers in the 100 series (between 100 and 180). The legal part defines the term color, based on the function, either to add or restore color to a food (Art. 1 § 2). Colors used for staining inedible external parts of foodstuffs are excluded.

It is extremely important to note that the maximum use levels authorized refer to the quantities of the ‘‘coloring principle’’ (i.e., the pure coloring substance) in the prepara- tion. As a rule, the authorization corresponds to the material, as it has been examined by the SCF.

Carry-over is regulated by Art. 3 (see also Sections V.J and V.N as well as Section Carry-over is regulated by Art. 3 (see also Sections V.J and V.N as well as Section

Annex II lists foodstuffs in which no colors may be used, except if provided for specifically in Annexes III, IV, or V. In addition to unprocessed foodstuffs, there are 32 other descriptors for such foods. An important one is foods for infants and young children (Annex II § 29 of Ref. 28). This prohibition also excludes ‘‘reverse carry-over’’ as a way to add color to such foods for the young.

Annex III lists foodstuffs in which, each time, only a limited number of specific colors may be used. These are put into 27 groups and indicate maximum use levels. The colors indicated in Annex III may also occur in Annexes IV and V.

Annex IV is a list of colors which are authorized only for specific foodstuffs. It also indicates maximum use levels. Annex V is split into two parts. Part 1 is a list of 15 colors (which are all different from the ones in Annex IV and Annex V, Part 2) that are permitted at QS level in all foodstuffs, except those listed in Annexes II and III. Hence they may also be used at QS in all the foods listed in Annexes IV and V, part 2. Part 2 of Annex V gives authorizations for 18 colors (which are all different from those in Annex IV and Annex V, Part 1). It is organized in two tables: a table with 18 colors and a table with some 30 food descriptors. Every color from the list may be used up to the maximum use level indicated for the food in the table—independently, alone, or in combinations. There is however an exception.

b. Exception Made for Children in Annex V, Part 2. For five of the foodstuffs in the table of Part 2, an exception is made. The foodstuffs for which an exception is made are nonalcoholic drinks, edible ices, desserts, fine bakery ware, and confectionary. All these foodstuffs are frequently consumed in copious amounts by children. Four items of the colors list are restricted in use level to no more than 50 mg per kilogram or per liter. The colors for which this exception is made are Sunset Yellow FCF, azorubine, cochineal red

A, and brown HT. The concern for protecting children is clear in this decision, since each of these colors has an ADI of less than 5 mg/kg body weight. For the other colors in the list of Part 2, there are no restrictions except for the maximum use levels indicated.

2. Implementation All member states must have adapted their national legislation by now so as to bring it

in compliance with the colors Directive. They are obliged already now to grant free circula- tion to complying products. Noncomplying products are banned from all of the EU market already.

3. Update An update Directive, as were issued for sweeteners (see Section VII.A.7) and for miscella-

neous additives (see Section VII.C.4.c), is not planned. No doubt this is because of the extreme sensitivity of the issue of colors in foods.

4. Azo-Colors Sweden joined the EU on January 1, 1995. Before that date it had already on the books 4. Azo-Colors Sweden joined the EU on January 1, 1995. Before that date it had already on the books

The EU Commission maintains that the SCF approved of the use of these colors in full knowledge of their occasional allergenicity (44). It considers the Swedish measure disproportionate, as other additives not prohibited in Sweden are sometimes as allergenic. And allergenicity cannot be a valid reason to prohibit an additive. Labeling of additives used in the ingredient list is the best protection for some rare individuals suffering from allergies against additives (see also Section IV.E).

5. Labeling Amazingly, notwithstanding the sensitivity of the public toward colors, and unlike for the

case of sweeteners, special labeling requirements for colors outside the ingredient list have never been proposed during the development of this Directive.

6. Specifications and Methods of Analysis The specifications for all authorized colors permitted in foodstuffs have been published

in the Official Journal (20). Two older methods of analysis for colors (pH and ether extractable compounds) have been laid down in Directive 81/712/EEC (48).

C. Miscellaneous Additives Directives

1. Structure and Annexes Miscellaneous additives Directives 95/2/EC (10) holds again articles and annexes.

In Art. 1 § 5 of the legal part of Directive 95/2/EC nine groups of products are classified as nonadditives. Article 2 § 2 of the legal part of the same Directive refers to Annex I to indicate the additives which may be used at QS in all foodstuffs except those mentioned in Annex

II and in Art. 2 § 3. Article 2 § 6 in the legal part states that the additives authorized for foods for particu- lar and nutritional uses are also to be found in this Directive.

A standard carry-over clause can be found in Art. 3. Annex I lists additives author- ized at Quantum Satis in all foods except the foodstuffs listed in Annex II. Annex II was drawn up to limit the applications of Annex I additives for a series of foods for which the legislators disliked overliberalizing the use of additives. Annex II lists, for example, foods for which vertical standards are in existence as well as some foodstuffs in which specific member states put a special pride (e.g., pasta, pain courant franc¸ais, certain wines, and mozzarella).

Annexes III and IV list the different additives with the descriptors for the foodstuffs in which they can be used, under the conditions mentioned therein. Annex V is the list of additives and one solvent which may be used as carriers, together with their conditions of use. Annex VI lays down, if four parts, which additives may be used in infant formulae, in follow-on formulae, and in weaning foods, and in foods for infants and young children for special medical purposes. In each of the four parts, the conditions of use are indicated

See Section V.H for the discussion of use levels on miscellaneous additives. One substance can be used sometimes in several functions. Only in the case of

sweeteners and colors have the specific functions been laid down in separate Directives. Consequently, one color and some of the sweeteners appear in more than one Directive.

The calcium carbonates (E170i and E170ii) have been authorized as colors (cf. Sec- tion VII.B.1), but are also authorized in the miscellaneous additives Directive. The polyols and some intense sweeteners as well were authorized in some functions in the miscellaneous additives Directive (cf. Sections VII.C.A.1.a and b.) The legislator’s intention to impose complementary labeling for sweeteners in foods (cf. Sections VI.E.3 and 4) has its legal basis in the sweeteners Directive (27). Hence, in legal terms the compulsory indication of additional warning labels on foods containing sweeteners cannot apply to foods which contain sweeteners on the basis of authorizations given by the miscellaneous additives Directive (10). From this viewpoint, the use of poly- ols in nonsweetening functions, or of some intense sweeteners as flavor enhancers, would not trigger the obligation to apply the sweetener warnings.*

2. Additive Function As stated, listing of an additive in the sweeteners or in the colors Directive is clearly

defining the function meant for the authorization. As mentioned (Section V.B), in the miscellaneous additives Directive the precise technological function for which an additive is used is not always laid down in the legislative text. Indeed, the Directive’s Annex IV just refers to ‘‘Other permitted additives.’’ The definitions of miscellaneous additives’ functions are laid down in Art. 1 § 3.

For antioxidants (see Annex III, Part B) and preservatives (see Annex III, Part A), for example, the function is clearly stated in Directive 95/2/EC (10). Still EDTA, though listed in Annex IV, is frequently referred to as an antioxidant too. Hence there are more additives with antioxidant function than the ones indicated in Annex III, Part B.

It remains a question whether nitrates/nitrites—indicated as preservatives in the Directive—can be used for their coloring effect in certain meat products, at levels below the maximum authorized, and below the level required for assuring an effective preserva- tive function.

3. Flour Treatment Agents Although ‘‘flour treatment agent’’ is defined as an additive function (Art. 1.§ 4 of Ref.

10), flour treatment agents would logically fit better among the processing aids (see Section III.E.2).

Some substances that were considered for that purpose have various functions in the miscellaneous additives Directive. The classical flour treatment agents historically include a series of emulsifiers (such as E471 through E475 and E481, E482, and E483) as well as the reactive agents, ammonium persulfate, ascorbate, azodicarbonamide, benzoyl peroxide, chlorine, chlorine dioxide, cysteine, potassium bromate, and sulfites. The emulsi- fiers have been assigned authorizations in the miscellaneous additives Directive (10). As

* This seems logically sound. Yet, if that were really so, the presence of aspartame in sugar-containing chewing gums, specifically authorized in the miscellaneous additives Directive (10) would not be highlighted as a warning outside the ingredient list to phenylketonuria patients. Still for ‘‘no added sugar’’ chewing gums, the same sweetener will trigger warning labeling, since for such chewing gums the authorization to use aspartame * This seems logically sound. Yet, if that were really so, the presence of aspartame in sugar-containing chewing gums, specifically authorized in the miscellaneous additives Directive (10) would not be highlighted as a warning outside the ingredient list to phenylketonuria patients. Still for ‘‘no added sugar’’ chewing gums, the same sweetener will trigger warning labeling, since for such chewing gums the authorization to use aspartame

The EU Commission’s SCF has rejected ammonium persulfate and potassium bro- mate. Further studies were requested on azodicarbonamide, chlorine, and chlorine dioxide before a final decision could be made. On benzoyl peroxide no data were found in the reports of the SCF, or in the minutes of its meetings.* Ascorbate is authorized by the main miscellaneous additives Directive (10). In the same Directive, there are a number of authorizations also for the sulfites, though not explicitly as flour treatment agents. (Yet the authorizations for use in starches and in dry biscuits may cover some of the needs.)

A community authorization has been given for l-cysteine in the second update of the miscellaneous additives Directive (10). Hence, except for the emulsifiers, ascorbate, l -cysteine, and sulfite, the other reactive candidate flour treatment agents are prohibited. The additives framework Directive—in its Art. 2 § 1 (4)—states that the additives lists of the EU are exclusive, in so far as such lists have been drawn up. The last but one citation of the main miscellaneous additives Directive refers flour treatment agents to a, then future, Directive to be drawn up after the SCF has evaluated them (10). Since the SCF has made its evaluations approving only l-cysteine, the case of the other flour treat- ment agents seems closed, until new data will be cleared by the SCF.

4. Corrigendum

A corrigendum to Directive 95/2/EC has been published in the Official Journal to correct ‘‘5 mg/kg’’ to read ‘‘5 g/kg’’ for phosphates in potato products (49). However, since a corrected table for the phosphates was introduced afterwards in Directive 98/72/EC (5), this corrigendum has completely lost its meaning.

5. Update Directives

a. First Minor Amendment. Directive 96/85/EC (24) authorizes alternatively refined carrageenan, E407a, by a special first updating Directive.

b. Second Amendment. As an important second update (98/72/EC) (5), in parallel with and for the same purpose as the amending update for sweeteners, the Commission issued an important update Directive on miscellaneous additives. In addition to authorizations re- quested to permit technological progress, some additional requests emanated from the new member states (Austria, Finland, and Sweden), which joined the Union on January 1, 1995.

A second enzyme is introduced as a new additive by Directive 98/72/EC (5): in- vertase. Other new additives appearing for the first time are mono- and dimagnesium phosphate, konjac gum and konjac glucomannane, β-cyclodextrin, cross-linked sodium carboxymethyl cellulose, enzymatically hydrolyzed carboxymethyl cellulose, microcris- talline wax, l-cysteine, and acetylated oxidized starch.

The entries on phosphates of Directive 95/2/EC (10) have been replaced by this draft proposal with a new improved table. A number of additional individual modifications and new foodstuff entries are also put forward in this second update Directive.

All newly proposed entries have been indicated with ‘‘UPM’’ (miscellaneous addi-

tives) in Appendix Tables 1 and 2 .

c. Toward Further Amendments to 95/2/EC. Article 5 of the framework Directive (4) permits member states to authorize new additives on trial within their own territories. As c. Toward Further Amendments to 95/2/EC. Article 5 of the framework Directive (4) permits member states to authorize new additives on trial within their own territories. As

It is likely that a fifth amending Directive will be issued some time later, after the additive intake surveys (see Section V.M) have been finalized in order to apply corrections and allow another adaptation to new developments.

6. Implementation of the Directives on Miscellaneous Additives All member states should bring their legislation in compliance with Directive 95/2/EC

(10) not later than September 25, 1996. Complying products will have to be granted free circulation as from the same date. Nonconforming products should already have been banned from all of the European Union.

7. Specifications for Miscellaneous Additives and Community Methods of Analysis

Updated specifications for additives other than colors and sweeteners have not yet all been finalized. Their elaboration is being continued.

After the new additives Directives were issued, miscellaneous additives have been issued: for E200 through E385, as well as for E1105, in Directive 96/77/EC (21); for E400 through E585 they can be found in Directive 98/86/EC (22). Additional specifications (E170 and E296 through E1520) are still being developed at the time this paper goes to press.

As the Commission has taken JECFA specifications as an important starting point for its work in this field, JECFA specifications could be used in absence of final EU specifications. However, earlier official EU specifications or the member states’ national specifications should take priority. In older Directives criteria for purity for certain miscel- laneous additives were already laid down for certain antioxidants (50), emulsifiers, stabi- lizers, thickeners, and gelling agents (51), and for certain preservatives (52,53).

A couple of generalities on methods of analysis, as well as some Community meth- ods of analysis for preservatives and antioxidants were also issued in an older Directive (48).