1 codex alimentarius commission FOOD AND AGRICULTURE WORLD HEALTH ORGANIZATION ORGANIZATION OF THE UNITED NATIONS JOINT OFFICE: Via delle Terme di Caracalla 00100 Rome Tel.: 39.06.57051 Telex: 625825-625853 FAO I E-mail Codex@fao.org Facsimile:39.06.5705.4593 Agenda Item 7e CX/FAC 01/9 February 2001 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON FOOD ADDITIVES AND CONTAMINANTS Thirty-third Session The Hague, The Netherlands, 12-16 March 2001 COMMENTS SUBMITTED ON THE USE OF FOOD ADDITIVES AS CARRIERS The following comment have been received from Canada, New Zealand, USA, CEFIC and ISDC CANADA There are a number of food additives, such as anticaking agents, emulsifiers and preservatives, that are used to enhance the utility of other food additives. For the most part, these are used in food additive preparations at the same type of levels as they would be used in foods. The exceptions are solid carriers and liquid solvents that are used as diluents for food additives to facilitate their introduction and distribution/dispersal in foods. Canada does not feel that the CGSFA should deal with these at length and, in any case, should certainly not attempt to regulate their levels in final foods as a result of their use in food additive preparations. Perhaps a simple list of substances recognized as solid carriers (e.g. sugar, salt, cyclodextrins) or solvents (propylene glycol, ethanol, etc.) for food additive preparations is all that is needed. NEW ZEALAND We recognise that some food additives (e.g. food colours, flavours, artificial sweeteners) are sold as preparations containing other food additives with a range of technological functions. The justification for such additives generally fit into either the stability of the preparation (e.g. preservative or antioxidant) or to achieve incorporation into the finished food (eg carriers, solvents). Noting also that food additives are traded internationally, it would appear desirable for CCFAC to consider provisions for food additive preparations in the GSFA.
2 A specific category for preparations of food additives could be introduced into the GSFA Food Category System. This would allow entries for food additive preparations to be made in Table 1 and Table 2. CCFAC should also consider whether it is appropriate that food additive preparations should be permitted to contain any food additive listed in GSFA Table 3, or whether all additives permitted should be specified in Table 1 and Table 2. That is, whether the list of foods annexed to Table 3 (which lists foods to which Table 3 does not apply) should include food additive preparations (our preferred approach). A number of Codex advisory specifications (ie JECFA Monographs) contain provisions permitting subsidiary food additives (eg preservatives, carriers). However, this is not the case for flavours and the format for these monographs is different to other food additives. Also, food additives are often not used in foods singly but are typically used in complex mixtures sold either as liquids in a solvent or as a powdered mixture. Therefore, flavour preparations, in particular, would need permission to contain food additives. The issue of food additive preparations has been addressed in the draft Joint Australia New Zealand Food Standards Code. The Joint Code includes a general standard for food additives (Standard 1.3.1), which has a category for food additive preparations listing specific food additive permissions. The Joint Code may be viewed on the Australia New Zealand Food Authority (ANZFA) website (www.anzfa.gov.au). Clarification is needed on the status of additives in food additive preparations in the finished foods. That is, are the additives permitted carried over additives, or as in some instances, are the additives processing aids (eg carriers)? USA The Codex Procedural Manual has established that a food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation treatment, packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly) in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods... The Codex Procedural Manual also establishes that a processing aid means any substance or material, not including apparatus or utensils and not consumed as a food ingredient itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product. The Codex definitions of food additive and processing aid do not explicitly exclude substances that are used as carriers for other additives. 1 Although the definitions of food additives, carriers and processing aids form a continuum rather than having clear distinctions, there are some important differences. For example, a food additive has an intended technical effect in the finished food as consumed, while a processing aid has its intended technical effect in the processing or treatment during manufacture of the food. Food additives are present in the finished food, while processing aids may or may not be present in the finished food. 1 Codex Alimentarius Commission: Procedural Manual, 11 th Ed., pp. 45 & 47, Rome, 2000.
3 Neither Codex nor JECFA have established a definition for a carrier. We offer the following definition for consideration by the CCFAC: a carrier is a food additive that is intended to facilitate delivery of another food additive or to stabilize another food additive or to otherwise enhance the other food additive s intended functional effect in the final food. The following examples illustrate different uses of carriers as defined above: (a) Dioctyl sodium sulfosuccinate (DSS) is approved in the United States of America for use as a solubilizer for gums and colloids that are used as stabilizers and thickeners in food [21 CFR 172.810(c)]. A solubilizer for hydrophilic gums and colloids is often necessary to prevent aggregation of the gum or colloid when added to water. The aggregates are practically impossible to solubilize and can be exceedingly unpalatable to consumers. Gums and colloids are often used in dry powder beverages to impart "body" or proper "mouth feel" to the reconstituted product. Treatment of these gums and colloids with DSS promotes more rapid hydration, which prevents aggregation when the colloid or gum is mixed with water. (b) Polysorbate 60 (PS 60) is approved in the United States of America for use as a surfactant or wetting agent for colors added to soft drink mixes, gelatin dessert mixes, and pudding mixes [21 CFR 172.836(c)(15)]. A number of natural and artificial colors are not readily soluble in water or food matrices. In order to enhance dispersion of the color, the addition of PS 60 to the color as a carrier has been found to be effective in improving the solubility of the color and reducing the amount of color needed to achieve the desired color in the final food. Polysorbate 60 is also effective as a carrier for flavors and colloids in gelatin desserts [21 CFR 172.836(c)(13)]. Gelatin desserts are commonly composed of gelatin as the colloidal gelling agent, an acidulant, a buffer salt, sugar or artificial sweeteners and flavor. The use of PS 60 as carrier for the gelatin and flavor components of a gelatin dessert mix improves the dispersion properties of the gelatin and flavor components of the mix, thereby improving the clarity of the gel. (c) -cyclodextrin (BCD) has been reported in the development of the GSFA for use as an encapsulating agent for flavors added to water-based beverages. BCD is intended to stabilize the flavor by providing a protective cage for the flavor (which is usually hydrophobic). This extends the shelf-life of flavors stored in a dry state. When the encapsulated flavor is added to a water-based beverage, BCD releases the flavor. (d) In the United States of America, substances that are generally recognized as safe or are approved food additives for use in baked goods may be used in combination with aspartame to ensure its functionality as a sweetener in finished baked goods. Such ingredients, or carriers, (e.g., triglycerides) can be used to coat granular aspartame in order to inhibit its decomposition during baking. The carriers melt during baking and release the aspartame into the food near the end of the baking cycle. In the examples above, the use of a carrier is necessary to optimize the technical effect of another additive in food as consumed. In these instances, the carrier is intended to be present in the final food and the concentration of the food additive for which it is acting as a carrier determines its concentration in the final food. The functional effect carrier solvent was included in the development of the draft GSFA because this function is included in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluations 2 that are the 2 Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) 1956-1997, Section 2, FAO/WHO 1999.
4 source of the acceptable daily intakes (ADIs) for the additives included in the GSFA. The JECFA term carrier solvents includes the terms carrier and carrier for flavour. The list of functional classes used by the Codex International Numbering System (INS) for food additives does not include carriers or carrier solvents. Recommendation The United States of America recommends that the CCFAC consider the following proposal to address the use of carriers in the GSFA: Food additives that are intended to facilitate the delivery of another food additive or to stabilize another food additive or to otherwise enhance another food additive s intended functional effect in the final food should be considered as carriers and should be included in the GSFA. CEFIC The CEFIC Food Regulation Panel supports a list of carriers for food additives be established which can be used following Good Manufacturing Practice or specified use conditions to be established if necessary. We believe that the list of carriers of Annex V of the Directive 95/2/EC of the European Union would be a good basis for such list and also propose the use conditions given in this directive be considered as the basis for the discussions of the CCFAC. We also note that additional substances may be required as additives for flavourings. ISDC At the 32nd session of CCFAC (March 2000), the Committee discussed the technological function of additives such as beta cyclodextrin and polyethyleneglycol in order to decide whether or not additives designated as carriers should be included in the GSFA. While the term carrier is listed as a function in the Summary of Evaluations Performed by JECFA, it is not listed as a function in the Codex General Standard for the Labeling of Prepackaged Foods, or in the INS Inventory or in the Codex Inventory of Processing Aids. In addition, there is no provision in the Preamble to the GSFA for the use of food additives that are regarded by some countries as processing aids. The situation with regard to carriers points out two questions that must be answered in order to continue with the elaboration of the GSFA. The first question is whether the GSFA should continue to be a list of substances used solely as food additives and which must be labeled as such, and the second question is whether or not to include in the GSFA food additives that are clearly processing aids or food additives that may be regarded by some countries as processing aids. ISDC recommends that in order for the GSFA to be useful as an international standard that can be adapted for use in all countries, it should be inventory of all food additives regardless of whether they are considered as food additives that have to be labeled or as food additives used in conjunction with other food additives that do not have to be labeled, e.g. processing aids. It should be left to national governments how they wish to consider the additive in their country. In order for Codex to provide comprehensive advice to governments and industry on the use of food additives regardless of their intended functions and without regard to whether or not they are to be labeled, it is necessary
5 to include advice on all food additive provisions, including processing aids. This would mean that carriers would be included. While we appreciate the work and efforts that went into the compilation of the Inventory of Processing Aids which is not a comprehensive list, it still contains provisions for both food additives and processing aids. In the past CCFAC has attempted to designate which additives are food additives and which are processing aids; but due to the disparity in food regulations throughout the world, there was no agreement. This is why when the Inventory of Processing Aids was published, it contained a note stating that it is for individual governments to decide what use they wish to make of the Inventory. We believe it is time for CCFAC to broaden the GSFA to include not only food additives but also food additives used as processing aids, without regard to function and without regard to labeling implications. Labeling is a matter that is already dealt with in the Codex General Standard for Labeling of Prepackaged Food, and this should be made clear in the Preamble to the GSFA. If CCFAC decides not to include processing aids in the GSFA, then a strongly worded and clear statement must be included in the Preamble to the GSFA making the status of processing aids clear and unambiguous.