BASIC CONCEPTS

III. BASIC CONCEPTS

A. Vertical Versus Horizontal Legislation

Food legislation is termed vertical when it pertains to a specific group of foods, that is,

a specific food category (for example, chocolate). Vertical legislation on a food category is sometimes called a food standard. It normally deals, in one text, with several or all relevant aspects of that food category, such as additives authorizations, specifications of additives, sales denominations, labeling, claims, contaminants, methods of analysis, sam- pling plans, official control, and so on.

A vertical law may be convenient for an operator in a specific sector, with little specialized knowledge of overall food law. Indeed such legislation may answer all ques- tions at once with one text. Still, vertical standards may easily constitute considerable impediments to progress and innovation. Updating adaptations of vertical measures has generally proven very hard to achieve. This specific aspect may have led the European Commission to change tack and opt for horizontal measures in order to further harmoniza- tion.

Such horizontal legislation is legislation dealing with only one aspect, but is applica- ble to all foodstuffs (except when specifically indicated). Such legislation is politically far more difficult to elaborate. It requires, indeed, for its development a very thorough knowledge of the entirety of the food chain, and of all the existing legislation, so as to foresee all consequences and to avoid conflicting implications of its general application.

B. European Versus Member States’ Authority

Driven by the will to open up the European market, or to create political unity, the actions of the European Community reflect the changing political mood of the time. Periods in which centralizing tendencies draw power to the central authority alternate with centrifugal Driven by the will to open up the European market, or to create political unity, the actions of the European Community reflect the changing political mood of the time. Periods in which centralizing tendencies draw power to the central authority alternate with centrifugal

a matter is to be dealt with at the level which can most efficaciously achieve the required results. But even in cases where Union authority is to take charge, the member states by their presence and voting rights in committees, in the Council of Ministers and also in the EP, wield a lot of power. It is inconceivable for Union legislation to see the light if it does not enjoy broad majority support from the member states.

C. Qualified Majority: Member States’ Power

In several committees, as well as in the European Council of Ministers, many important decisions have to be made by qualified majority. In such cases the member states are allotted a number of votes, roughly proportional to their relative weight in the Union: 10 votes each for the larger countries (France, Germany, Italy, and the United Kingdom), 8 votes for Spain, and a lesser number for each of the smaller countries. The allotment of votes tends to give a disproportionately greater weight to the smaller countries, com- pared to the size of their populations. It is expected that these numbers of votes allotted to member states will be correspondingly adapted as more countries join the Union.

D. The European Legislative Environment

1. The Parties Involved New European legislation is always prepared by the European Commission (or the ‘‘Com-

mission,’’ the ‘‘Parliament,’’ the ‘‘Council’’) before further proceedings leading to adop- tion. For important measures with political implications—such as the authorizations of additives—the joint EP and the Council of Ministers adopt the measures according to well- established procedures (see Section D.2). In its preparations, the Commission consults with interested parties, such as member states’ government experts, industry, consumers, traders, agriculture, etc. In these consultations, associations—organized by sector and/or by member state—are important partners. But individual businesses and advisors can also have input. The directly elected representatives of Parliament are gaining ever more impor- tance in the process (see Section II.C). Throughout all stages of the proceedings to develop the legislation, both the Council and the Commission cooperate intensively, through com- mittees, with experts from the member states’ administrations.

One of the important committees assisting the Commission in matters of food is the Standing Committee for Foodstuffs. It is essentially a voting college of experts ap- pointed by the member states and presided over by the Commission. This committee takes its decisions by qualified majority (the number of votes weighted to the different coun- tries). Other committees and institutions, such as the Advisory Committee on Foodstuffs and the Economic and Social Committee have only an advisory role.

Without being a legislating institution, the European Court can be asked—on a case by case basis—to interpret the legislation. Certain technical matters do not need to be regulated by law, but can be more flexibly agreed by standardization. In this way, the European Standardization Committee (CEN) became one more partner in the process of harmonization of European food legislation as far as, for example, methods of analysis and voluntary codes of practice per sector are

See Section X.B for sources of information regarding Commission bodies and proce- dures.

2. The Legislative Instruments

a. The Main Four Instruments. In the European Union regulatory landscape, four types of measures are prominent: Recommendations, Decisions, Directives, and Regulations. Both the Council and the Commission can take each of these. But recently, as already stated, important measures with political implications are taken jointly by Parliament and Council.

Recommendations are not legislation, and therefore have no binding effect. Decisions are only binding for those to whom they are addressed. Directives and Regulations are generally binding in the whole Union.

A Regulation is directly applicable as such. Hence, for issues for which strict reliabil- ity and conformity of legislation are required, Regulations are the preferred legal tool. This is, for example, the case for novel foods. (See Section III.E.6.1.)

b. Directives. The main legislative instruments in the Union are Directives. Directives are binding only as far as the result aimed at is concerned. For a Directive to be applicable, however, every member state has first to implement it—transpose it into its own legislation according to its own internal legal system. This process does, of course, entail clear risks for the equivalence of the resulting legislation.

The concept of Directives was developed in order to cope with the fact that the legal systems in the individual member states are quite different. Directives are the key European Union legislative instruments, aimed at permitting the implementation of the measures in each member state, fitting into, and respecting, the national legislative struc- tures and traditions of each state. Directives have been extremely useful tools that have strongly advanced the European harmonization process. However, they are frequently not implemented in a timely way, triggering the Commission to undertake corrective action. Most of the recent food legislation is drawn up in the form of Directives.

Before undertaking to regulate an extensive domain of importance (such as, for example, additives or flavorings), the rules of procedure, the general criteria applicable, as well as the underlying rationale are laid down in a so-called framework Directive.

c. Numbering of Directives. The framework Directive on additives was published as the 107th Directive of the year 1989. It therefore received the number 89/107/EEC,* even

* The extension EEC stands for European Economic Community. From sometime in 1993, and conse- quent to the Treaty on European Union (Maastricht Treaty), measures refer to European Community (EC). A similar but independent numbering system applies to the other types of measures. Hence the mere number does not unambiguously identify a text of European law. In principle one also has to know whether, for example, a Directive or a Decision is meant. For example, Council decision 95/2/EC carries the same number code as the Directive on sweeteners, 95/2/EC. The Council decision 95/2/EC, however, establishes the order in which the presidency of the Council shall be held and is not related to sweeteners.

On the other hand, Regulations are indicated with: No/year. Examples are the vertical regulations of 1989: Regulation (EEC) No 1576/89 on spirit drinks, and of 1994: Regulation (EC) No 2991/94 on spreadable fats.

Lately the year indicator carries the full four digits 1999/ . . . for Decisions and for Directives, and N ° Lately the year indicator carries the full four digits 1999/ . . . for Decisions and for Directives, and N °

d. Format of the Legislative Texts. The overall format of the European legislative texts on additives comprises a legal part and annexes. Tabulated data and fine print, as well as technical detail, are generally laid down in the annexes (such as the tables of additives and their conditions of use). Unfortunately these important tables can neither be found in the official legislative database of the EU (‘‘Celex’’; see Section X.B) nor in a number of derived information systems.

The legal part consists of articles and is generally preceded by the underlying moti- vation in a number of citations (‘‘whereases’’).

e. Translation and Publication. The services of the Council take care to translate all measures into each of the official languages of the Union, and publish the text—issued simultaneously in all member states—in the different language versions of the Official Journal of the European Communities (OJ), recent issues of which are available on the Internet. For ease of consultation, the publishers of the OJ print the documents so that the same items can be found in identical locations (page numbers) in the different language versions of the journal.

f. Characterizing Dates, Implementation, and Enactment. Normally the last articles of

a Directive or Regulation indicate (1) the limiting dates at which the member states have to adapt their legislation, so as to align them with the Directive or Regulation requirements, (2) the date from which products in conformity with the measure should gain free circula- tion, and (3) the date from which products not in compliance with the requirements of the measure must be prohibited.

In addition to these dates, a Directive or Regulation can be characterized by its date of adoption which is mentioned in the title, the date at which it enters into force, and the date of its publication (i.e., the OJ reference).

3. Development: Two Main Procedures One of two main development procedures have to be followed, depending on the nature

of the measure. Measures of a technical or detailed implementation nature can normally

be dealt with by the Commission, in discussion with the member states’ administration experts, so far without involvement of the Council or the Parliament’s politicians. The mandate given to the Commission for these measures is generally laid down in another Directive, adopted according to the second procedure (see below). Examples of such mea- sures are the specifications for additives. The precise procedure which is to be followed for the adoption of such a measure can normally be found in one of the articles of the Directive that mandates the Commission to take the measures.

Important measures with political implications, however, must be adopted jointly by the EP and the Council (i.e., by political appointees) by the so called co-decision procedure . In this procedure, Parliament—in a first reading—examines a Commission proposal and proposes amendments. Similarly, the Economic and Social Committee (ECOSOC) is required to give an opinion on the proposal at this stage of the procedure. Normally the ECOSOC opinion is the first one to be issued, and this tends to set the trend.

At the same time, the Council prepares a political common position based on the Commission proposal, on the Parliamentary amendments, and on any other relevant ele-

Council and Parliament then have to come to terms, which sometimes requires an intricate conciliation procedure. The EP adoption of the concluding joint EP–Council conciliation texts is also called the third reading. It is beyond the bounds of this chapter to develop the precise intricacies of the procedure which may lead to adoption or rejection of a proposal. It will be clear though that developing a measure is a very lengthy undertaking.

Any approval to use an additive in a specific foodstuff is considered such a political decision and is subject to this procedure. Hence, more and more, the food and additive manufacturers will have to watch out for political aspects of their innovations and take care to properly sell the concepts of their new products to consumers and politicians (see Section VIII).

4. Arbitration on the Meaning of the Additive Texts The Standing Committee for Foodstuffs is the official body for arbitrating whether a

substance is a food additive (rather than a novel food, for example) and whether a foodstuff comes under one of the food descriptors or food categories occurring in the Directives on additives.

This specific authority is neither controlled by the Council nor by the EP. It should

be clear that the Standing Committee for Foodstuffs cannot give new authorizations. That can only be done through the lengthy authorization procedure, involving European Com- mission, Council, and Parliament.

Given the important mission of the Standing Committee for Foodstuffs, it is most worrisome that—so far—this body has not published reports on its deliberations nor did it issue official summaries of its decisions. A whole series of decisions on, for example, the exact meaning of the food descriptors in the additives Directives has already been made. Democracy and true transparency would be served by very fast publication of, and easy access to, any decisions made by that Committee.

E. Definitions and Scope of Additives Legislation

With respect to the length of the approval procedure for additives in the EU, the question as to what is and what is not an additive is a very important one.

1. Definition of Additive The definition of additive is laid down as follows in Art. 1 of Directive 89/107/EEC (4): For the purposes of this Directive ‘food additive’ means any substance not normally consumed

as a food in itself and not normally used as a characteristic ingredient of food whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.

2. Processing Aids Versus Additives Processing aids are defined as follows in Directive 89/107/EEC (4): For the purpose of this Directive, ‘processing aid’ means any substance not consumed as a

food ingredient by itself, intentionally used in the processing of raw materials, foods or their food ingredient by itself, intentionally used in the processing of raw materials, foods or their

The same substance can sometimes be used either as an additive or as a processing aid. It depends—in principle—on the intention of its application, whether the substance exerts its effect in the final food or merely during the manufacturing process.

Sulfites are clear examples of such a double option; they can be used as additives (e.g., as preservatives), but also as processing aids (e.g., as bleaching agents for candy products or for ‘‘marinated’’ nuts).*

The definitions for additives and for processing aids are built on earlier ones from Codex Alimentarius. Yet they differ from these in some aspects. They do not always allow one to establish unambiguously whether a substance added to food is an additive or a processing aid. Dimethyldicarbonate (E242) is a case in point. After years as a processing aid in Germany, the European Union has now made E242 into an additive. Another exam- ple is hexylresorcinol. It is a very effective inhibitor of the polyphenoloxidase in the shell of crustaceans. It could be applied to prevent ‘‘black spot’’ discoloration in shrimps, for example. Hence it can act as a replacement for sulfite in that function. Hexylresorcinol could be considered the perfect example of a processing aid. However, several public authorities insist now on considering it an additive anyhow.

It is most remarkable that the EU definition of additive in English (and related lan- guages) differs from the one in French (and related languages) in a point that heavily bears on the classification of a substance either as an additive or as a nonadditive (generally, a processing aid). The English-type version states that—in case of an additive—the sub- stance or its byproducts can become part of the final food. The French-type version speaks about the substance or its derivatives (instead of byproducts) to become part of the food.

Byproducts, in contrast to derivatives, are admixtures present in the original prepara- tion. Derivatives are produced essentially after addition of the preparation to the food. It should be noted that this difference follows, in all likelihood, from the same difference between the English and French definitions already in place in Codex Alimentarius.

In the cases referred to above, the derivatives produced (methanol and carbon diox- ide from dimethyldicarbonate and the bound inhibitor moiety from hexylresorcinol) led to classification of the preparations added as non–processing aids, although their outspoken reactivity in the manufacturing or premanufacturing processes only might have perfectly allowed their classification as processing aids.

Certain substances can act as flour treatment agents. They exert their effect during the production of baked goods. In the finished product, they do not play a functional role. Hence it could be concluded logically that they should be termed processing aids. How- ever, flour treatment agents are listed among the additive functions in Annex I of the framework Directive on Additives (4) (see Table 1 ). Therefore, l-cysteine has been listed as an additive (5).

* In the case of sulfites—and that is the only one in the combined additives Directives up to now—a footnote states that the sulfite quantities in the Directive refer to the totality of all sulfite present (i.e., any natural sulfite; sulfite produced by the manufacturing process, such as in brewing; sulfite added as an additive; and

Table 1 The Function Categories of Additives Established for Authorization Purposes

Categories of food additives Color

Preservative Antioxidant Emulsifier Emulsifying salt Thickener Gelling agent Stabilizer Flavor enhancer Acid Acidity regulator Anticaking agent Modified starch Sweetener Raising agent Antifoaming agent Glazing agent Flour treatment agent Firming agent Humectant Sequestrant Enzyme a Bulking agent Propellant gas and packaging gas

a Only those used as additives. Source : Ref. 4.

It should be stressed that in Community law processing aids are not ingredients. Up to now some countries, such as Spain, Germany, and Denmark, have considered processing aids as a subgroup of additives. It is interesting to watch whether these countries will change their legislation in that respect. In any case, in a communication of the Danish Ministry of Public Health of December 18, 1995, concerning the new Community legisla- tion on additives, the classification of processing aids as a subclass of additives has been maintained.

The formal consequences of classifying a substance as an additive (in contrast to classification as a processing aid) are that (1) a heavy safety dossier has to be submitted to the Scientific Committee for Food, (2) the substance has to be indicated in the ingredient list on the label, (3) a Community authorization for use has to be obtained, and (4) the use levels have to be agreed upon by the authorities.

Although a manufacturer always has to ensure the complete safety of the final food- stuffs they are marketing, there is no EU Community obligation to formalize authorization, safety studies, and risk evaluation for processing aids. Except for solvents, there is no Although a manufacturer always has to ensure the complete safety of the final food- stuffs they are marketing, there is no EU Community obligation to formalize authorization, safety studies, and risk evaluation for processing aids. Except for solvents, there is no

Solvents have already been regulated by specific Directives (6–8). But, so far, for processing aids as a group, Community legislation has not been planned.

3. Enzymes Versus Additives There have been rumors that (after solvents) enzymes would be the second class of pro-

cessing aids for which Community legislation might be put forward. The creation of legal certainty in this field is of benefit to the food industry, on the strict condition that it does not lead to multiplication of requirements in the legislation. Although enzymes derived from genetically modified organisms (GMOs) (mainly from microorganisms) constitute the majority of food enzymes for the future, other, non-GMO enzymes are also of impor- tance to the food industry.

Rules on enzymes of GMO origin have not been laid down in the Regulation on novel foods (9). It would indeed be quite illogical to regulate enzymes in the Regulation on novel foods and novel food ingredients, since processing aids are neither foods nor food ingredients in EU law.

Although enzyme is an established function of additives as well (see Table 3 ), so far only two enzymes have been listed as authorized additives in the miscellaneous additives Directives: lysozyme (10) and invertase (5). Other enzymes are, so far, considered pro- cessing aids.

4. Nutrients Versus Additives Substances added to food for their nutritional effect (e.g., certain vitamins, certain miner-

als, and certain amino acids) are not additives. They can sometimes, however, also be used for a technological purpose, that is, as additives (e.g., ascorbic acid as an antioxidant). In that case, an authorization (case of need, conditions of use, etc.) is required.

5. Foods Versus Additives In EU food law, there is (so far, again) no firm definition of what is a food. Hence, the

question whether something is a food or an additive is bound to arise regularly. A recog- nized nutrient function can be an argument in order to declare something a food. Still, chewing gum can be without nutrient function, yet it is generally still food (it can also

be a cosmetic or a medicinal product). Clearly, organoleptic pleasure is also a criterion to declare something a food. Additives must be used for predominantly technological functions (see Section V.B). However, many, if not all, undisputed foods have clear tech- nological functions as well: sugar is a sweetener;* a humectant, a thickener, and it is the most important of all; cocoa powder gives color, etc. The same is true for the polyols. Still, suggestions have been made to reclassify the polyols as foodstuffs since they also have a nutritional function. The authorities will generally prefer to classify substances as additives when they wish to maintain firm control over their conditions of use. A regular foodstuff is indeed not subject to conditions of use.

* It is most remarkable in this context that the framework Directive’s definition of additives (4) states that for a substance to be an additive, it is irrelevant whether the substance has nutritive value. Hence the

Additives can have nutritive value (see the definition of additives in Section III.E.1). There has been a long debate as to whether the modified starches are additives or food- stuffs. The EU legislation now considers organochemically modified starches as additives. On the other hand, products obtained from starch by mere hydrolysis and by amylolytic enzymes are considered nonadditives, that is, foods.

6. Novel Foods Versus Additives Nowhere are such questions more pressing than for novel substances. Since January, 1997,

the EU has a Regulation on novel foods (9). Up to now, and according to the principle of ‘‘one door, one key,’’ the European Commission has refused to have additives regulated outside the additives Regulations proper. Hence, it has resisted requests, from several sides, to bring additives derived from genetically modified organisms (GMOs) within the scope of the novel foods Directive. Giving in would mean additional hurdles to the intro- duction of GMO-derived additives. (Additives derived from GMOs would have to go through both the procedure for authorization of additives and the procedure for authoriza- tion of novel foods.)

In order to neutralize criticism about this refusal, the European Commission has declared that approved additives, whose method of preparation is switched from classical production techniques to different ones (e.g., employing GMOs as their source) would have to be resubmitted for SCF scrutiny. In preparation for this, the European Commission made certain specifications (see also Section III.H) of certain additives with detail on the mode of preparation.

New substances can be considered as either novel foods or additives, depending on whether they have essentially a nutrient function or essentially a technological function. Whether the function of a substance is nutritional or technological can be far more contro- versial than would immediately appear. In the field of fat replacers for example, it is up for debate whether a lipid with lower or zero energy effect is still a nutrient or whether it is to be assigned a mere bulking agent (additive) function.

EU authorization of a new additive is an expensive and tedious process, requiring two (or even three) readings in the EP. Such an authorization may take several years. In principle, a novel food authorization should be faster, as it does not have to go through the heavy Parliament procedures, and as it does not have to be implemented in the national legislations of the member states. Time will show whether that proves to be the case.

7. Flavorings and Solvents Versus Additives Flavorings, and processing aids (including, e.g., solvents and enzymes), as well as nutri-

ents, are not additives in the forthcoming legislation. For solvents, Community legislation is already in place (6–8).

On flavorings and flavoring substances, other specific Community legislation is al- ready enacted (11–15) or is in the process of being completed (16,17). Certain substances, classified earlier as additives in certain member states have now been reclassified as fla- voring substances for the EU legislation. Examples are the maltols, ammonium chloride, and formic acid.

It should be noted in this context that there is, so far, no really good definition in EU legislation for flavorings nor for flavoring substances. The European Commission has been asked to start harmonizing the field of additives for flavorings. Up to now—this area not being regulated at the European level—industry

A list of additives for flavorings is in preparation. It is not yet certain that the list will finally hold only additives authorized already as the regular additives Directives or whether entirely different substances might also be considered for inclusion. For example,

a substance used by flavorists, and which is so far neither listed among authorized solvents nor among authorized additives is benzyl alcohol. It must also be decided which conditions of use or labeling provisions will be added. Art. 6 § 4(c)ii of the general labeling Directive 79/112/EEC (18) states: ‘‘. . . shall not

be regarded as ingredients . . . substances used in the quantities strictly necessary as sol- vents or media for additives or flavoring.’’ Hence, so far, they need not appear in the ingredient list on food labels.

F. Additive Authorization in the EU

In order to give consumers confidence in the safety of food additives authorized in the EU, authorities provided long ago acceptable food additives with an unambiguous identi- fication number, preceded by an E.* This initiative was torpedoed by the infamous ‘‘Tract

de Villejuif ’’ pamphlet, which spread the message that E numbered additives constituted

a special health hazard. This malevolent disinformation, which is still circulating widely, continues unfortunately to cause considerable confusion and uncertainty in the minds of the European consumer.

The new Directives authorize 365 additives. This seemingly high number has pro- voked criticism from consumers and from members of the EP. However, that number is extremely misleading because its magnitude is a consequence of the rather arbitrary defi- nition of what an additive is in the EU and of the way E numbers are assigned. The public at large has come to distrust substances merely because they are categorized as additives and carry an E number . It should be realized, though, that the mere administrative catego- rization of a substance as an additive does not affect the properties—physical or biologi- cal—of that substance so as to entail a risk by its use.

In many cases slightly different forms of the same substance carry their own different

E numbers (e.g., sodium, potassium, calcium salts of an acid; and for the phosphates alone

24 different numbers are listed so far). Furthermore, ordinary ambient gases (oxygen, carbon dioxide, and nitrogen) were also given additive status with an E number. The same is true for the noble gases argon and helium. Although these two are so far rarely if ever used, they are normal minor constituents of air as well.

Moreover, the mere number of authorized additives is meaningless. Indeed, additives with different E numbers may fulfil similar functions; that is, they are mutually exclusive in use for a certain application or alternatively they are used in combinations with a lower concentration for each component of the mixture applied (e.g., for sweeteners).

A considerable number of natural food components are also termed additives in the legislation when added as separate substances. Some of these, such as acetic acid, propi- onic acid, ascorbic acid, citric acid, lecithin, etc., could also be properly considered as

* Note in this context that the E numbering system in the EU came into existence before the INS number- ing system of Codex Alimentarius and served as a model for the latter one. In this chapter, indicating E numbers along with the verbal additive names with every additive reference in the text has been avoided in order to improve readability. The reader may consult Table 2 in order to find the E numbers corresponding to an additive name where needed.

foods in their own right. And as has been mentioned (Section III.E.5), many other com- pounds, such as the modified starches and the polyols, might very well be classified as foods. Furthermore, a number of the other additives are extremely close to, or identical with, regular food components, such as, for example, E471: mono- and diglycerides of fatty acids.

The example of a simple tomato illustrates the point. It contains naturally nine E number substances.* Furthermore, many salt ions can all be found in the tomato (potas- sium, sodium, calcium, chloride, etc.). Combined in different ways, they would lead to a considerable number of E numbers for the same natural foodstuff.

A list of all additives authorized by the EU Directives can be found in the Appendix Table 1 , (sorted by E number) and Appendix Table 2 , (sorted alphabetically) at the end of this chapter. In both these tables the corresponding Directives in which they are author- ized are indicated, along with all the page numbers on which they appear.

Listing of additives, along with their conditions of use in the tables of the Directives, constitutes the corresponding authorization. For colors there is an additional table with a mere enumeration of all authorized substances, as a separate annex to the legislative text (see Section VII.B.1.a).

G. Compilation of Needs: CIAA Database

In 1990, CIAA (the Confederation of the Food and Drink Industries of the EU) established in a computer database for internal usage its ‘‘wish list’’ of food additive needs. This database was established in preparation for the consultations offered by the Commission during the drafting of the additives Directives. This exercise was probably the first attempt to draw a pan-European picture of food additive usage in Europe. Although it has been replaced by the European legislation discussed here, this original database is at the origin of the actual system of authorizations now in place in the EU.

H. Specifications and Methods of Analysis

Specifications updated after the new additive authorizations came in place have been is- sued for sweeteners (19) and for colors (20). For the miscellaneous additives, the updated specifications are not yet complete (21,22).

Methods of analysis are not described in the new European additive specifications. Lately, the European authorities prefer avoiding issuing Community methods of analysis by legislation. Instead, they refer elaboration and validation of such methods to standard- ization organizations (CEN, etc.). The main general rules applicable to sampling and meth- ods of analysis for the Community are given in an earlier Directive (23). See Sections

VII.A, B, and C for detail on Community specifications, as well as on Community methods of analysis laid down in earlier legislation. In each of the recent EU additive specifications Directives (19–22), a citation can

be found which is quite important to developers of additives; it reads

* E621 (monosodium glutamate), E622 (monopotassium glutamate), E623 (calcium diglutamate), E625 (magnesium diglutamate), E300 (ascorbic acid), E301 (sodium ascorbate), E160a (mixed carotenes), E160d (lycopene), and E101 (riboflavine).

Whereas food additives, if prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or if different from those mentioned in this Directive, should be submitted for evaluation by of the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria . . .

This means, for example, that before the replacement of the raw commodity for the manu- facturing of an authorized additive by a GMO-derived raw material, the SCF should be consulted before the change. Indeed, GMO-derived materials are considered to be different (see also Section III.G.6).